FDA UDI In Commercial Distribution 🇺🇸 United States

Closed Circuit Foley Catheter Tray - Sterile - 18 FR

DI: 00616784500737 · Model: 5007 · Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

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Basic Information

Brand Name
Closed Circuit Foley Catheter Tray - Sterile - 18 FR
Primary DI
00616784500737
Version / Model
5007
Company Name
Dynarex Corporation
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2018-08-18
Public Version
4
Public Version Date
2024-10-09
Public Version Status
Update
Public Device Record Key
beb4a48d-d250-4e8a-9a8a-49f58858bffd

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OHR Catheter Care Tray

GMDN Terms

Code Name
61355 Urethral catheterization support kit, urinary drainage

Identifiers

Type ID
Primary 00616784500737
Unit of Use 00616784500720