DEVICE: NA (04546540867247)

Device Identifier (DI) Information

NA
0225028514
In Commercial Distribution
0225028514
STRYKER CORPORATION
04546540867247
GS1

1
196548481 *Terms of Use
CBCII Blood Conservation Kit with Round PVC Drain and Curved Trocar
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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.
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FDA Product Code

[?]
Product Code Product Code Name
CAC APPARATUS, AUTOTRANSFUSION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K970714 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

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

06989901-c92b-47ab-97bc-c28ab70ca111
July 06, 2018
3
September 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
34546540867248 6 04546540867247 In Commercial Distribution pack
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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