FDA.report

MaxBlend

Primary DI
00853061006272
Brand
MaxBlend
Company
MAXTEC, LLC
Model
R203P05-001
Device description
MaxBlend Low Flow Air Oxygen Blender - DISS Fitting
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications

CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853061006272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853061006272008530610062728530610062720853061006272

GMDN Terms

TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Device Sizes

TypeValueUnit
Height7.25Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
169911828
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
false
Sterilization required before use
false

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