FDA.report

Resp-O2 Oxygen Supply Tubing

Primary DI
00840117311565
Brand
Resp-O2 Oxygen Supply Tubing
Company
DYNAREX CORPORATION
Model
33201
Device description
Resp-O2 Oxygen Supply Tubing 7' (2.1m) Crush Resistant Tube, Universal Connector
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117311565PackageGS150In Commercial Distribution
00840117311558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117311565008401173115658401173115650840117311565
00840117311558008401173115588401173115580840117311558

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
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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