FDA.reportPublic FDA data

Resp-O2 Oxygen CO2 Pressure Line Filters

Primary DI
00840117316171
Brand
Resp-O2 Oxygen CO2 Pressure Line Filters
Company
Dynarex Corporation
Model
33087
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
00840117316096PackageGS150In Commercial Distribution
00840117316171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117316096008401173160968401173160960840117316096
00840117316171008401173161718401173161710840117316171

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.

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true

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00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24
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00616784914213CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91422016-09-24
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00616784010113Aluminum Crutches - Youth101012019-09-30
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