FDA UDI In Commercial Distribution 🇺🇸 United States

GLOBAL HEALTHCARE

DI: 00872237001804 · Model: 60-T02 · GHC HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
GLOBAL HEALTHCARE
Primary DI
00872237001804
Version / Model
60-T02
Company Name
GHC HEALTHCARE, INC.
Labeler DUNS
884718776
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-16
Public Version
1
Public Version Date
2023-03-24
Public Version Status
New
Public Device Record Key
78186ea2-38d1-4190-ac2c-216461c4498b

Device Description

UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000 CC, SYRINGE 10 CC PRE-FILLED WITH STERILE WATER, VINYL GLOVES (1 PAIR), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, WRAP, PVP SWAB STICKS (3).

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

GMDN Terms

Code Name
61355 Urethral catheterization support kit, urinary drainage

Identifiers

Type ID
Package 40872237001802
Primary 00872237001804