FDA.reportPublic FDA data

BIRD SENTRY2

Primary DI
10846446065107
Brand
BIRD SENTRY2
Company
Carefusion Corporation
Model
30624-003
Catalog number
30624-003
Device description
LOW FLOW 0-3 FLOWMETER FRENCH
Published
2017-03-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446065107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644606510710846446065107

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, dial-typeA device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752101876TiaraTMS-2820912016-09-13
10190752101883TiaraTMS-2821912016-09-13
10190752101890TiaraTMS-2830912016-09-13
10190752101913TiaraTMS-2831912016-09-13
10190752101920TiaraTMS-2840912016-09-13
10190752101944TiaraTMS-2841912016-09-13
10190752101951TiaraTMS-2850912016-09-13
10190752101975TiaraTMS-2851912016-09-13
10190752102033TiaraTMS-12032016-09-13
10190752102040TiaraTMS-1203782016-09-13
10190752102057TiaraTMS-12532016-09-13
10190752102064TiaraTMS-1253782016-09-13
10190752102071TiaraTMS-14032016-09-13
10190752102088TiaraTMS-1403782016-09-13
10190752102095TiaraTMS-25202016-09-13
10190752102101TiaraTMS-25402016-09-13
10190752102118TiaraTMS-2540782016-09-13
10190752102125TiaraTMS-28202016-09-13
10190752102132TiaraTMS-28302016-09-13
10190752102149TiaraTMS-28402016-09-13

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Primary DI, Brand, Company table
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