FDA.report

Composite Respiratory Kit: Performance Home Medical

Primary DI
10709078002547
Brand
Composite Respiratory Kit: Performance Home Medical
Company
WESTMED, INC.
Model
0836
Device description
Composite Respiratory Kit: Performance Home Medical 2-0194B, 2-0556B, 1-0027B, 1-0052B, 1-No Smoking Sign, 2-0590B
Published
2017-04-20
Public version status
Update
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
10709078002547PackageGS110In Commercial Distribution
00709078002540PrimaryGS10

GMDN Terms

TermDefinition
Oxygen administration tubingA length of flexible tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2) or an O2 enriched gas to a mask or nasal cannula, typically during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. 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
true
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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