FDA.reportPublic FDA data

Resp-O2 Portable Oxygen Liter Meters

Primary DI
00840117318694
Brand
Resp-O2 Portable Oxygen Liter Meters
Company
Dynarex Corporation
Model
33309
Published
2021-04-22
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
BXYFlowmeter, Calibration, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXYFlowmeter, Calibration, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117318618PackageGS18In Commercial Distribution
00840117318694PrimaryGS10
00840117319899Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318618008401173186188401173186180840117318618
00840117318694008401173186948401173186940840117318694
00840117319899008401173198998401173198990840117319899

GMDN Terms#

Term, Definition table
TermDefinition
Portable liquid oxygen unitAn empty device designed as a portable, supplemental, refillable container intended as a storage for liquid oxygen (LOX) and its conversion into gaseous form for delivery of medical oxygen (O2) at various pulsed or fixed flow settings to a patient who typically has difficulty extracting O2 from the atmosphere. It typically consists of a cryogenic canister containing the LOX, a mechanism (e.g., a warming coil) where the LOX is converted into gas, a gas delivery control device (e.g., demand valve or fixed flow mechanism) that regulates the flow of O2 to the patient, a fill port and an outlet connection for connection of a nasal cannula or face mask.

Regulatory Flags#

DUNS number
008124539
Device count
15
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10848530105508REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
00026072022443EMAllied Medical, LLCBXY2024-09-16
00026072022450EMAllied Medical, LLCBXY2024-09-16
00026072022467EMAllied Medical, LLCBXY2024-09-16
00026072022474EMAllied Medical, LLCBXY2024-09-16
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00817770025870ManifoldMAXTEC, LLCBXY2024-08-14
00817770025955ManifoldMAXTEC, LLCBXY2024-08-14
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00026072022511EMAllied Medical, LLCBXY2024-05-28
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07640214642844FlowMeter F2IMT Analytics AGBXY2023-09-18
07640214642851FlowMeter F1IMT Analytics AGBXY2023-09-18
07640214642868FlowMeter F2IMT Analytics AGBXY2023-09-18
00851440007599Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007605Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007612Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00817770022442BlenderBuddyMAXTEC, LLCBXY2023-06-08
00817770025726FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025733FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025740FlowmeterMAXTEC, LLCBXY2023-06-08
07640214642400CITREX H4IMT Analytics AGBXY2022-11-17
07640214642417CITREX H5IMT Analytics AGBXY2022-11-17