FDA UDI In Commercial Distribution 🇺🇸 United States

Uni-Lim 72" Anesthesia Circuit

DI: 00709078009259 · Model: 8041 · WESTMED, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Uni-Lim 72" Anesthesia Circuit
Primary DI
00709078009259
Version / Model
8041
Company Name
WESTMED, INC.
Labeler DUNS
092673953
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-31
Public Version
2
Public Version Date
2022-10-24
Public Version Status
Update
Public Device Record Key
06b3e17a-cc95-419c-aba7-c0d7bce28ddd

Device Description

Uni-Lim 72" Anesthesia Circuit, Adult, Co-Axial Breathing Circuit, GSE, B/V Filter, 2L Not made with latex

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
CAH Filter, Bacterial, Breathing-Circuit
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)

GMDN Terms

Code Name
37704 Anaesthesia breathing circuit, single-use

Identifiers

Type ID
Package 10709078009256
Primary 00709078009259

Premarket Submissions

Submission Number Supplement Number
K922492 000