FDA.report

NasoClear Nasopharyngeal Airway ID Size 7.0mm 30 Fr

Primary DI
05055788732822
Brand
NasoClear Nasopharyngeal Airway ID Size 7.0mm 30 Fr
Company
FLEXICARE MEDICAL LIMITED
Model
038-95-007CU
Published
2020-01-10
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
05055788732822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788732822050557887328225055788732822

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
504406273
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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