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
OTC
false
Sterile
false
Single use
false

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
00810180847346Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318618008401173186188401173186180840117318618
00840117318694008401173186948401173186940840117318694
00810180847346008101808473468101808473460810180847346

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

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Primary DI, Brand, Company table
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00848530105501REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
20848530105208REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
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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00817770025863ManifoldMAXTEC, LLCBXY2024-08-14
00817770025870ManifoldMAXTEC, LLCBXY2024-08-14
00817770025955ManifoldMAXTEC, LLCBXY2024-08-14
00848530020019CPAP AccesorySUNSET HEALTHCARE SOLUTIONS, INC.BXY2024-06-17
00026072022511EMAllied Medical, LLCBXY2024-05-28
07640214642837FlowMeter F1IMT Analytics AGBXY2023-09-18
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