Disposable Heated Humidified Circuit Kit

GUDID 00709078005374

1- 0503-01 1- 9586

WESTMED, INC.

Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use
Primary Device ID00709078005374
NIH Device Record Key58f34487-1946-4f11-8f2c-2b961b6040fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Heated Humidified Circuit Kit
Version Model Number9658
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078005374 [Primary]
GS110709078005371 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2018-02-05

On-Brand Devices [Disposable Heated Humidified Circuit Kit]

007090780053741- 0503-01 1- 9586
107090780053641- 9586 1- 0562-01
10709078005111FloEasy™ Co-Flo, Disposable Heated Humidified Circuit Kit

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