DEVICE: CBCII Consta Vac (07613154128365)

Device Identifier (DI) Information

CBCII Consta Vac
0225029000
In Commercial Distribution
0225029000
STRYKER CORPORATION
07613154128365
GS1

1
196548481 *Terms of Use
Blood Collection Only System with PVC Drains and Double Trocar
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Whole-blood-recovery autotransfusion system, manual An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is actuated by the operator (e.g., by squeezing a bellows/bag). A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CAC APPARATUS, AUTOTRANSFUSION
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter: 3.2 Millimeter
CLOSE

Device Record Status

6024951f-6cfa-44f7-b8f8-8c26c98abf98
March 29, 2018
2
September 23, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
37613154128366 6 07613154128365 In Commercial Distribution pack
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
CLOSE