ABG-PROVENT 1ML LI M POINTLOK& 200/CA

Registration Details

Registration Name: Sterigenics U.S., LLC
Registration Number: 1319639
FEI Number: 1000138054
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 84 Park Rd
City: Queensbury
State: NY
ZIP: 12804
Country: US

Regulatory Submissions

510(k) Number: K952516

Owner / Operator

Firm Name: Sotera Health LLC
Operator Number: 10029425
Address: 2015 Spring Road, Suite 650
City: Oak Brook
State: IL
Postal Code: 60523
Country: US
Correspondent: Karen Whaley-Krumins

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	Class 2	Clinical Chemistry	No	2012-11-20

Proprietary Names

ABG-PROVENT 1ML LI M POINTLOK& 200/CA SY(VAP PROVT-LI HP)3ML-LL** ProVent Plus Arterial Blood Sampling Kits PRO-VENT PLUS,1CC L/S SYRINGE 25GX5/8IN NEEDLE,FILTER-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-LINEDRAW 3ML LI M % 200/CA ABG 1 ML LINE DRAW 7 IU HEPARIN DRYLITHIUM + 200/CA LineDraw Plus Arterial Blood Gas Kits ABG-PROVENT 3ML LI M, 22 X 1 1/4, NP + 100/CA ABG-PROVENT 1ML LI F & 100/CA ProVent Plus Arterial Blood Sampling Kits ABG PROVENT 1ML LI F & 100/CA ABG-LINE DRAW 3ML LI M, + 100/CA ABG UMBILICAL LINEDRAW 3ML LI M 200/CA ABG LINEDRAW 1ML/3ML LI + 100/CA ABG-PULSATOR 3ML LI M + 200/CA ABG-PROVENT 1ML LI F & 100/CA PRO-VENT PLUS 3CC L/S SYRINGE 23GX1,22GX1.5INNDL,FLT+NDL-PRO 100/CA ProVent Plus Arterial Blood Sampling Kits *PhO*-ABG-PROVENT 3ML LI F + 100/CA ABG-PROVENT 3ML LI M + 100/CA LINE DRAW PLUS DRY 3CC SYRINGELUER SLIP, FILTER-PRO 200/CA LineDraw Plus Arterial Blood Gas Kits ABG - LINEDRAW 3ML LI M 200/CA ABG-PROVENT 3ML LI M + 200/CA *PhO*-ABG-PROVENT 3ML LI M + 200/CA ABG-PROVENT 1ML LI F & 100/CA ABG-LINEDRAW 1ML LI F + 200/CA ABG-PROVENT 3ML LL NO NEEDLE + 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-LINE DRAW 1ML LI M, & 100/CA ABG-PROVENT 3ML LI M, + 100/CA ABG-PROVENT 3ML LI M, 23 X 1, NP + 100/CA ABG-LINEDRAW 1ML LI M + 100/CA PROVENT 1CC 23G 100/CA ABG-LINE DRAW 1ML LO-LI M + 200/CA ABG-PROVENT 3ML LI M, 23 X 1 1/4, NP + 100/CA ABG-PROVENT 1ML LI M, 23 X 1, NP & 100/CA ABG LINEDRAW 1ML LI M ST + 200/CA PRO-VENT PLUS,1CC L/S SYRINGE 23GX1IN NEEDLE-FILT+NDLE-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LL 21 IU HEPARIN DRYLITH 200/CA PRO-VENT LUER SLIP NEEDLE REPLACEMENT IS 4645PE 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 1ML LS 7 IU HEPARIN DRYLITH & 200/CA ProVent Plus Arterial Blood Sampling Kits PRO-VENT PLUS 25GX5/8IN NEEDLE1CC SYR, NP & FILTER-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PULSATOR 3ML LI F - EDGE 100/CA Pulsator Plus Blood Sampling Kit ABG-PULSATOR 3ML LI M + 200/CA Pulsator Plus Blood Sampling Kit PRO-VENT-1ML, 23G X 1IN NE-PRO REPLACEMENT IS 4629PE 200/CA ProVent Plus Arterial Blood Sampling Kits DRY LINEDRAW,ARTERIAL SAMPLING1ML L/SLIP SYR,FILT-PRO DEVICE 200/CA LineDraw Plus Arterial Blood Gas Kits ABG-PROVENT 3ML LS 21 IU HEPARIN DRYLITH + 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-LINEDRAW 1ML LI M % 200/CA LineDraw Plus Arterial Blood Gas Kits PRO-VENT PLUS 25GX5/8IN 1CC SYR, EDGE & FILTER-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-LINE DRAW 3 ML LL 21 IU HEP/DRYLITH + 200/CA LineDraw Plus Arterial Blood Gas Kits PRO-VENT PLUS, 3CC L/S SYRINGE23G *1IN NEEDLE,FILT+NDLE-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LI F POINTLOK % 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-LINEDRAW 3ML LI M % 200/CA LineDraw Plus Arterial Blood Gas Kits SY(VAP VENTED-LI HP)1ML-LS ** ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 1ML 25X5/8 POINTL& 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 1ML 25X5/8 POINTL & 100/CA ProVent Plus Arterial Blood Sampling Kits LINE DRAW, DRY HEPARIN, 1CC SYRINGE, LUER SLIP, FILTER-PRO 200/CA LineDraw Plus Arterial Blood Gas Kits PRO-VENT 22GX1IN 3CC SYR, EDGE & FILTER-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 1ML LI F - EDGE 100/CA ProVent Plus Arterial Blood Sampling Kits PRO-VENT PLUS,1CC SYRINGE 23GX1IN NEEDLE, FILTER-PRO 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LI M POINTLOK+ 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LI M EDGE + 200/CA ProVent Plus Arterial Blood Sampling Kits *PhO*-ABG-LINEDRAW 3ML LI M % 200/CA LineDraw Plus Arterial Blood Gas Kits SY(VAP PROVT-LI HP)3ML-LS** ProVent Plus Arterial Blood Sampling Kits DRY LINEDRAW,ARTERIAL SAMPLING3ML L/SLIP SYR,FILT-PRO DEVICE 200/CA LineDraw Plus Arterial Blood Gas Kits ABG-PROVENT 3ML LI M + 200/CA ProVent Plus Arterial Blood Sampling Kits LINE DRAW, DRY HEPARIN, 3CC SYRINGE, LUER LOCK, FILTER-PRO 200/CA LineDraw Plus Arterial Blood Gas Kits ABG-PROVENT 3ML LI F % 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LI F - EDGE 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LI F + 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 1ML LS 7 IU HEPARIN DRYLITH & 100/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML 22X1 POINTLOK+ 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PROVENT 3ML LS 21 IU HEPARIN DRYLITH + 200/CA ProVent Plus Arterial Blood Sampling Kits ABG-PULSATOR 3ML LI F % 100/CA Pulsator Plus Blood Sampling Kit ABG-PROVENT 3ML LI F + 100/CA *PhO*-ABG-LINEDRAW 3ML LI F + 100/CA ABG-PROVENT 3ML LI F POINTLOK % 100/CA ABG LINEDRAW 3ML LI M 200/CA ABG-UMBILICAL LINEDRAW 3ML M 200/CA ABG-PROVENT 3ML LI F POINTLOK % 100/CA ABC-PROVENT 1ML LI F & 100/CA ABG LINEDRAW 1ML LO LI + 100/CA ABG-PROVENT 3ML F + 100/CA ABG-PROVENT 3ML LI M, 22 X 1, NP + 100/CA ABG-PROVENT 1ML LI F & 100/CA ABG-PROVENT, 1 ML LI M, & 100/CA ABG-PROVENT 1 ML 200/CA ABG-PROVENT 3ML LI M 200/CA K952516 ABG-PROVENT 3ML + 100/CA ABG-PULSATOR 3ML LI F + 100/CA ABG-PROVENT 1ML LI F POINTLK & 100/CA ABG-PROVENT 3ML LI F + 100/CA *PhO*-ABG-PROVENT 3ML LI F POINTLOK % 100/CA ABG-PROVENT 1ML LS 7 IU HEPARIN DRYLITH & 200/CA ABG-PULSATOR 3ML LI F + 100/CA ABG-PULSATOR 3ML LI F +100/CA 3ML PRO-VENT SYRINGE 25G X 5/8IN NDLE & FILT PRO 200/CA ABG-PULSATOR 3ML LI M + 100/CA ABG-LINEDRAW 1ML LI F + 100/CA ABG-PROVENT 1ML LI F 100/CA ABG-PROVENT 3ML LI F % 100/CA ABG-LINEDRAW 1ML LI F % 100/CA ABG-LINEDRAW 1ML LI M + 200/CA ABG-PROVENT 1ML 25X5/8 POINTLOK & 100/CA ABG-LINEDRAW 3ML LI M + 200/CA PROVENT L/SLIP SYRINGE 1ML 22G NEEDLE,NEEDLE PRO,FILT-PRO 100/CA ABG PROVENT 3ML LI F + 100/CA ABG-PROVENT 1ML LI M, 25 X 5/8, NP & 100/CA

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)