FDA.report

Resp-O2 Nasopharyngeal Airways, 32 FR

Primary DI
00840117323360
Brand
Resp-O2 Nasopharyngeal Airways, 32 FR
Company
DYNAREX CORPORATION
Model
36281
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications

CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117315341PackageGS110In Commercial Distribution
00840117315433PackageGS110In Commercial Distribution
00840117323360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117315341008401173153418401173153410840117315341
00840117315433008401173154338401173154330840117315433
00840117323360008401173233608401173233600840117323360

GMDN Terms

TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. 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
false
Sterilization required before use
false

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