FDA UDI In Commercial Distribution 🇺🇸 United States

Critiflo™

DI: 10884450323165 · Model: 10884450323165 · ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10

Basic Information

Brand Name
Critiflo™
Primary DI
10884450323165
Version / Model
10884450323165
Catalog Number
682060/A
Company Name
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Labeler DUNS
595138793
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2019-11-27
Public Version
2
Public Version Date
2021-12-13
Public Version Status
Update
Public Device Record Key
1cdbc490-3649-4e03-bda9-3578bee6d6c0

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KRA Catheter, continuous flush

GMDN Terms

Code Name
63612 Invasive blood pressure monitoring flush tubing

Identifiers

Type ID
Package 20884450323162
Primary 10884450323165
Unit of Use 00884450323168