FDA.reportPublic FDA data

Resp-O2 50 PSI Compressor

Primary DI
00840117324008
Brand
Resp-O2 50 PSI Compressor
Company
Dynarex Corporation
Model
33952
Device description
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Published
2022-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072634000EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.2008-11-19BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117327498PackageGS11In Commercial Distribution
00840117324008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117327498008401173274988401173274980840117327498
00840117324008008401173240088401173240080840117324008

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Serial number
true

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00616784010014Aluminum Crutches - Child101002019-09-30
00840117346505PA Safety Lancets, Pressure Activated, 21 G Needle71132026-06-01
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00616784213132Shoe Cover Non-Conductive, Universal21312021-06-21
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00616784213439Shoe Cover Non-Conductive, Non-Skid, X-Large21342021-06-21
00616784426518IV Pole Kit For Enteral Irrigation, Non-Sterile42652021-09-01
00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
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00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
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00840117309050Resp-O2 Single Suction Catheter, 18 FR320062022-05-10

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