DEVICE: NA (04546540867438)
Device Identifier (DI) Information
NA
0225028851
Not in Commercial Distribution
0225-028-851
STRYKER CORPORATION
0225028851
Not in Commercial Distribution
0225-028-851
STRYKER CORPORATION
CBCII Collection Bag
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a34c0b74-abd7-4309-a218-a105d6341fa6
August 25, 2023
6
September 24, 2015
August 25, 2023
6
September 24, 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 |
---|---|---|---|---|---|
34546540867439 | 10 | 04546540867438 | 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