FDA UDI In Commercial Distribution 🇺🇸 United States

Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs

DI: 00616784429038 · Model: 4290 · DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs
Primary DI
00616784429038
Version / Model
4290
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2018-09-13
Public Version
4
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
283c4229-293b-44f6-9506-5ca37807dd27

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
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
KNX Collector, Urine, (And Accessories) For Indwelling Catheter

GMDN Terms

Code Name
58923 Wearable adult urine collection bag, open-ended

Identifiers

Type ID
Primary 00616784429038
Unit of Use 00616784429014