FDA.reportPublic FDA data

Resp-O2 Compressor, 50 PSI

Primary DI
00840117324008
Brand
Resp-O2 Compressor, 50 PSI
Company
Dynarex Corporation
Model
33952
Published
2022-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

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

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.

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784432120Cotton Tipped Plastic Applicators43212021-09-01
00616784432526Wooden Spoon, 3" (7.6 cm)43252026-04-27
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR362602022-05-17
00840117313385Resp-O2 Intubating Stylette, 6 Fr362652022-05-17
00840117313408Resp-O2 Intubating Stylette, 10 Fr362662022-05-17
00840117313422Resp-O2 Intubating Stylette, 12 Fr362672022-05-17
00840117315235Resp-O2 Intubating Stylette, 14 Fr362682022-05-17
00840117317451Resp-O2 Endotracheal Tube Cuffed, 4.0 mm362342024-10-24
00840117317468Resp-O2 Endotracheal Tube Cuffed, 4.5 mm362352024-10-24
00840117317482Resp-O2 Endotracheal Tube Cuffed, 5.5 mm362372024-10-24
00840117317499Resp-O2 Endotracheal Tube Cuffed, 6.0 mm362382024-10-24
00840117317505Resp-O2 Endotracheal Tube Cuffed, 6.5 mm362392024-10-24
00840117317512Resp-O2 Endotracheal Tube Cuffed, 7.0 mm362402024-10-24
00840117317529Resp-O2 Endotracheal Tube Cuffed, 7.5 mm362412024-10-24
00840117317536Resp-O2 Endotracheal Tube Cuffed, 8.0 mm362422024-10-24
00840117317543Resp-O2 Endotracheal Tube Cuffed, 8.5 mm362432024-10-24
00840117317550Resp-O2 Endotracheal Tube, Cuffed, 9.0 mm362442024-10-24
00840117318366Resp-O2 Durable Peak Flow Mouthpiece, With One-Way Valve, Adult361162021-04-22
00840117318373Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric361172021-04-22
00840117318380Resp-O2 Cardboard Peak Flow Mouthpieces, Disposable, Adult361182021-04-22

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Primary DI, Brand, Company table
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00038214001797Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
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10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
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00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07