FDA.reportPublic FDA data

Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve

Primary DI
00840117338135
Brand
Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve
Company
Dynarex Corporation
Model
36394
Published
2024-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ECXCylinder, Compressed Gas, And Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECXCylinder, Compressed Gas, And ValveAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117338135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117338135008401173381358401173381350840117338135

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen refillable cylinderA container designed as a refillable cylinder used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials and must be used together with a pressure regulator in order to release the O2 at the correct working pressure. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.

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
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
00840117351905Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter, Control Valve32001S2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810051632491ICON 2 / VirtairControl Devices, LLCECX2025-07-08
00810051632422Control DevicesControl Devices, LLCECX2025-06-02
00810051632439Control DevicesControl Devices, LLCECX2025-06-02
00810051632446ICON 2Control Devices, LLCECX2025-06-02
05400992008643Ceodeux S.A - MeditecCEODEUX S.A.ECX2025-03-12
05400992008650Ceodeux S.A - MeditecCEODEUX S.A.ECX2025-03-12
00810051632378ICON 2Control Devices, LLCECX2024-11-22
G2982515100iFillControl Devices, LLCECX2024-07-25
G2982515110iFillControl Devices, LLCECX2024-07-25
G298254910iFillControl Devices, LLCECX2024-07-25
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 LDynarex CorporationECX2024-07-25
00840117338074Resp-O2 M15 Oxygen Jumbo D-Cylinder 2.9 L with CGA870 Toggle Valve Dynarex CorporationECX2024-07-25
G2982515101iFillControl Devices, LLCECX2024-07-25
G2982515111iFillControl Devices, LLCECX2024-07-25
G298254911iFillControl Devices, LLCECX2024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7LDynarex CorporationECX2023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post ValveDynarex CorporationECX2023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post ValveDynarex CorporationECX2023-12-29
05430003710005SMTCEODEUX S.A.ECX2023-11-20
05430003710036SMTCEODEUX S.A.ECX2023-11-20
05430003710012SMTCEODEUX S.A.ECX2023-11-20
05430003710043SMTCEODEUX S.A.ECX2023-11-20
05400992002221Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002573Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002641Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002689Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002726Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002740Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002863Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07
05400992002887Ceodeux S.A - MeditecCEODEUX S.A.ECX2023-11-07