FDA UDI In Commercial Distribution 🇺🇸 United States

Acosta Uro-Gard

DI: 00860012266807 · Model: 90-2003-001 · Acosta Medical Group, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Acosta Uro-Gard
Primary DI
00860012266807
Version / Model
90-2003-001
Catalog Number
90-2003-001
Company Name
Acosta Medical Group, Inc.
Labeler DUNS
081186149
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-02-19
Public Version
1
Public Version Date
2025-02-27
Public Version Status
New
Public Device Record Key
1b5237a5-c7ba-4799-8a74-117fa9576225

Device Description

Uro-Gard Urinary Collection Bag

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile

GMDN Terms

Code Name
58921 Non-wearable adult urine collection bag, open-ended

Identifiers

Type ID
Primary 00860012266807