DEVICE: CBCII ConstaVac (04546540867667)
Device Identifier (DI) Information
CBCII ConstaVac
0225416000
Not in Commercial Distribution
0225-416-000
STRYKER CORPORATION
0225416000
Not in Commercial Distribution
0225-416-000
STRYKER CORPORATION
Blood Conservation Kit PVC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46263 | Whole-blood-recovery autotransfusion system, manual |
An assembly of manual devices intended to be used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after surgery. It is a closed-circuit system that typically includes a manual aspiration (suction) pump, a collection container, reinfusion bag, safety clamps, non-return valves, blood screening filters, and a transfusion set; a drain(s) and/or trocar(s) may also be included in the system. It may facilitate connection to the wall outlet of a vacuum system for aspiration. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAC | APPARATUS, AUTOTRANSFUSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter: 6.4 Millimeter |
Device Record Status
77673fd4-afb5-4411-9416-010b92c32cc7
August 24, 2023
6
September 23, 2015
August 24, 2023
6
September 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
34546540867668 | 6 | 04546540867667 | 2019-04-01 | Not in Commercial Distribution | pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com