FDA.reportPublic FDA data

BIRD SENTRY2

Primary DI
10846446065114
Brand
BIRD SENTRY2
Company
Carefusion Corporation
Model
30624-004
Catalog number
30624-004
Device description
LOW FLOW 0-30 FLOWMETER DISS
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
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446065114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644606511410846446065114

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413838406Patient Monitor Edan Instruments, Inc.CCL2025-09-05
04036616010856Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
04036616013871Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
10889483588628Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590058Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590065Vital Signs™AirLife Finland OyCCL2025-04-07
20889483588632Vital Signs™AirLife Finland OyCCL2025-04-02
20889483588656Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588670Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588694Vital Signs™AirLife Finland OyCCL2025-03-31
00817770025665Oxygen SensorMAXTEC, LLCCCL2024-08-14
00817770025849AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025931AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025948AnalyzerMAXTEC, LLCCCL2024-08-14
04036616009102Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
04036616010979Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
00813841022281Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00813841022298Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00817770025641Oxygen SensorMAXTEC, LLCCCL2023-06-08
00817770025658MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025689MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025788Oxygen SensorMAXTEC, LLCCCL2023-06-08
10190752190955Vital Signs™Vyaire Medical OyCCL2023-05-30
10190752190962Vital Signs™Vyaire Medical OyCCL2023-05-30
70190752191237Vital Signs™Vyaire Medical OyCCL2023-05-30
04036616010900Oxygen SensorEnviteC-Wismar GmbHCCL2022-06-17
00852470008150Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
00852470008174Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
B9671501000S3AAei Technologies, Inc.CCL2021-11-03
04250320600985O2-SensorIT Dr. Gambert GmbHCCL2021-09-24