FDA.reportPublic FDA data

Resp-O2 Oxygen CO2, 7'(2.1m) Sampling Line, Female / Female Connector

Primary DI
00840117316126
Brand
Resp-O2 Oxygen CO2, 7'(2.1m) Sampling Line, Female / Female Connector
Company
Dynarex Corporation
Model
33082
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K143150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143150000CO2 monitoring line with and without in-line filterBesmed Health Business Corp2015-02-05CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117316041PackageGS125In Commercial Distribution
00840117316126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117316041008401173160418401173160410840117316041
00840117316126008401173161268401173161260840117316126

GMDN Terms#

Term, Definition table
TermDefinition
Capnography sampling adaptorA non-sterile device intended to enhance the capture of exhaled end-tidal carbon dioxide (EtCO2) for evaluation of a patient's ventilatory, circulatory, or metabolic status, typically during the administration of anaesthesia. It is an adhesive, dome-like adaptor with connecting ports designed to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
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00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
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00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

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