FDA.report

Resp-O2 Oxygen Mask Medium-Concentration

Primary DI
00840117310568
Brand
Resp-O2 Oxygen Mask Medium-Concentration
Company
DYNAREX CORPORATION
Model
33008
Device description
Resp-O2 Oxygen Mask Medium-Concentration, Elongated Pediatric, 7' (2.1m) Crush Resistant Tubing, Universal Connector
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117310568PackageGS150In Commercial Distribution
00840117310551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117310568008401173105688401173105680840117310568
00840117310551008401173105518401173105510840117310551

GMDN Terms

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.

Sterilization Methods

Method

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
false
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

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00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
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00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
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00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
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00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
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