FDA.report

Bird Blender

Primary DI
10846446002201
Brand
Bird Blender
Company
Carefusion Corporation
Model
15625
Catalog number
15625
Device description
SENTRY BLNDR/ANALYZR,HI FLO,DISS
Published
2015-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications

CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10846446002201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084644600220110846446002201

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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-231-2466support.smcvent.us@carefusion.com

Regulatory Flags

DUNS number
830432451
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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