FDA.report

O2 Composite Kit

Primary DI
10709078008372
Brand
O2 Composite Kit
Company
WESTMED, INC.
Model
HCO100
Device description
O2 Composite Kit
Published
2020-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OGLOxygen Administration Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078008372PackageGS110In Commercial Distribution
00709078008375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800837210709078008372
00709078008375007090780083757090780083750709078008375

GMDN Terms

TermDefinition
Oxygen administration kit, non-sterileA collection of non-sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20889483542887AMBU Hyperinflation System900 000 6062026-03-05
20889483542924AMBU Hyperinflation System900 000 6092026-03-05
20889483542962AMBU Hyperinflation System900 000 6112026-03-05
10709078000574VixOneVOID 02482025-11-24
00709078049996FilterVoid OU812b2025-09-23
00709078050008FilterVoid OU812a2025-09-23
10709078008402Flex Extenders7-51322024-09-25

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