FDA.reportPublic FDA data

NAZORCAP Sampler

Primary DI
00856824006137
Brand
NAZORCAP Sampler
Company
Nasorcap Medical, Inc.
Model
Model No. 9801-M4
Device description
Nasal ETCO2 Cannula with Male Filter
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911970000NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICENasorcap Ent., Inc.1992-08-14CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30856824006060PackageGS125In Commercial Distribution
40856824006067PackageGS1100In Commercial Distribution
00856824006137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085682400606030856824006060
4085682400606740856824006067
00856824006137008568240061378568240061370856824006137

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Contacts#

Phone, Email table
PhoneEmail
412-855-6916nasorcap@yahoo.com

Regulatory Flags#

DUNS number
803689769
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856824006014NAZORCAP SamplerModel No. 9112-T/FB2016-02-08
00856824006038NAZORCAP SamplerModel No. 9801-FB2016-02-08
00856824006052NAZORCAP SamplerModel No. 9801-FBL2016-02-08
00856824006069NAZORCAP SamplerModel No. 9801-F42016-02-08
00856824006106AirWave0802-M2018-01-18
00856824006113AirWave0802-L2018-01-18
00856824006007NAZORCAP SamplerModel No. 9112-T2016-02-08
00856824006021NAZORCAP SamplerModel No. 9801-F2016-02-08
00856824006045NAZORCAP SamplerModel No. 9801-MB2016-02-08
00856824006083NAZORCAP Bite Guard18012018-03-25
00856824006090AirWave0802-S2018-01-18
00856824006182ENDOCAP Bite Block17092018-03-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14