FDA UDI In Commercial Distribution 🇺🇸 United States

Urocare® Reusable Latex Leg Bag 26 oz. (800 mL.)

DI: 00792293095268 · Model: 9526 · UROCARE PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Urocare® Reusable Latex Leg Bag 26 oz. (800 mL.)
Primary DI
00792293095268
Version / Model
9526
Catalog Number
9526
Company Name
UROCARE PRODUCTS, INC.
Labeler DUNS
070637129
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-06
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
e1ab23bf-4491-4fd4-8dd3-f2b6e50d4edf

Device Description

BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LONG-SLIM, 26 FL. OZ. (800 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile

GMDN Terms

Code Name
58924 Open-ended wearable urine collection bag, non-sterile

Identifiers

Type ID
Primary 00792293095268

Customer Contacts

Phone
909-621-6013

Device Sizes

Type Value Unit Text
Weight 0.38 Pound
Total Volume 26 Fluid Ounce
Total Volume 800 Milliliter
Depth 1 Inch
Width 3.75 Inch
Height 20.63 Inch