FDA UDI In Commercial Distribution 🇺🇸 United States

120" Anesthesia Breathing Circuit

DI: 00709078009662 · Model: 9187 · WESTMED, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
120" Anesthesia Breathing Circuit
Primary DI
00709078009662
Version / Model
9187
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
343398cd-512e-455b-812d-b9ed7ed38c68

Device Description

120" Anesthesia Breathing Circuit, B/V Filter, GSE 10' x .060 ID M/M GSL, In-line Mini HMEF, Parallel WYE w/Temperature Port and GSP, 3L not made made with latex bag, 900 large adult mask

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
Primary 00709078009662
Package 10709078009669

Premarket Submissions

Submission Number Supplement Number
K922492 000