FDA UDI In Commercial Distribution 🇺🇸 United States

Kabi Access Infusion Sets

DI: 10813153028008 · Model: FK70110K · Codan US Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Kabi Access Infusion Sets
Primary DI
10813153028008
Version / Model
FK70110K
Company Name
Codan US Corporation
Labeler DUNS
058027475
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-27
Public Version
1
Public Version Date
2025-09-04
Public Version Status
New
Public Device Record Key
31577e8e-514a-426a-91ca-7d0f4dfe7692

Device Description

Manifold 2 Port 4-way stopcocks and rotating male Luer-lock

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
No
Has Serial Number
No
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
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
32172 Intravenous line stopcock

Identifiers

Type ID
Package 00813153028001
Primary 10813153028008