FDA.reportPublic FDA data

Resp-O2 O2 Medium-Concentration Elongated Mask

Primary DI
00840117310513
Brand
Resp-O2 O2 Medium-Concentration Elongated Mask
Company
Dynarex Corporation
Model
33006
Device description
7' (2.1m) Crush Resistant Tubing Universal Connector, Adult
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
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117310520PackageGS150In Commercial Distribution
00840117310513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117310520008401173105208401173105200840117310520
00840117310513008401173105138401173105130840117310513

GMDN Terms#

Term, Definition table
TermDefinition
Partial-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It includes a reservoir bag used for inhaling a mixture of exhaled and fresh gases. It is made of non-conductive, soft, flexible polymers available in a range of sizes, designed to create an airtight seal against the patient's face and may also include tubing, and various valves and connectors; other equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

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
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
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22
00840117311596Resp-O2 Oxygen Supply Tubing332032021-04-22
00840117311619Resp-O2 Oxygen Supply Tubing332042021-04-22
00840117311633Resp-O2 Oxygen Supply Tubing332052021-04-22
00840117311657Resp-O2 Oxygen Supply Tubing332062021-04-22
00840117311671Resp-O2 Oxygen Supply Tubing332072021-04-22
00840117311695Resp-O2 Oxygen Supply Tubing332082021-04-22
00840117318625Resp-O2 Oxygen Tubing Inline Water Traps333022021-04-22
00840117318632Resp-O2 Oxygen Tubing 22mm I.D. x 5-7 mm Tapered Nipple Adaptors333032021-04-22
00840117318649Resp-O2 Oxygen Tubing 5-7 mm End Adaptors333042021-04-22
00840117318663Resp-O2 Oxygen Tubing Y Adaptors333062021-04-22
00840117318670Resp-O2 Oxygen Tubing Nut Nipple Adaptors333072021-04-22
00840117318687Resp-O2 Oxygen Tubing Nut Nipple Swivel Adaptors333082021-04-22
00840117318694Resp-O2 Portable Oxygen Liter Meters333092021-04-22
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing331982025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO233199-F2025-06-09
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117310254Resp-O2 Oxygen Concentrator, 5L339502022-05-10

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