FDA UDI In Commercial Distribution 🇺🇸 United States

UNIVERSAL F® FLEX2®

DI: 00612649214542 · Model: AF476-17621Z · King Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
UNIVERSAL F® FLEX2®
Primary DI
00612649214542
Version / Model
AF476-17621Z
Catalog Number
AF476-17621Z
Company Name
King Systems Corporation
Labeler DUNS
009299017
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-18
Public Version
1
Public Version Date
2023-01-26
Public Version Status
New
Public Device Record Key
cc25f95c-8c4b-400d-ab52-1ea4f18e7771

Device Description

UNIVERSAL F FLEX2 CIRCUIT

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CAI Circuit, breathing (w connector, adaptor, y piece)

GMDN Terms

Code Name
37704 Anaesthesia breathing circuit, single-use

Identifiers

Type ID
Package 00612649214535
Primary 00612649214542

Customer Contacts

Phone
+14107686464

Device Sizes

Type Value Unit Text
Device Size Text, specify Adult / Pediatric