FDA Registration
Active
🇺🇸 United States
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280)
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1047843
- FEI Number
- 1047843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2072 SOUTHPORT RD., HWY. 295
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29306
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2012-11-14 |
Proprietary Names
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280)
PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060)
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281)
PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058)
Merit1383 (SN) - Cultura Saliva Self Collection Kit
Providien2420 (NT) - Shaped Specimen Bowl
CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories
Providien2420 (NT) - SPECIMEN BAG
Providien2420 (NT) - Specimen Wrap
BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes
Providien2420 (NT) - Orange Specimen Labels
Providien2420 (NT) - 120cc Medicine Cup and Lid
Providien2420 (NT) - Orange Specimen Wrap
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)