FDA UDI In Commercial Distribution 🇺🇸 United States

Geri-Gentle

DI: 10369771000174 · Model: 21-490 · GERI-GENTLE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
Geri-Gentle
Primary DI
10369771000174
Version / Model
21-490
Company Name
GERI-GENTLE CORPORATION
Labeler DUNS
361663839
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2016-11-10
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
80782646-4dfe-4e55-9d6a-ee1215f74dde

Device Description

FOLEY CATHETER TRAY 30cc

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
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
OHR Catheter Care Tray

GMDN Terms

Code Name
45605 Single-administration urethral catheterization kit, single-use

Identifiers

Type ID
Primary 10369771000174
Unit of Use 50369771000177