AccessGUDID - DEVICE: NA (04546540184788)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0212010000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0212010000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540184788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: 3/4 Perforation Flat Silicone Wound Drain

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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, powered	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 typically actuated by a central vacuum system. 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.

GMDN Preferred Term Name

GMDN Definition

Whole-blood-recovery autotransfusion system, powered

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 typically actuated by a central vacuum system. 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.

FDA Product Code

[?]

Product Code	Product Code Name
CAC	APPARATUS, AUTOTRANSFUSION

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 7.0 Millimeter

Device Record Status

Public Device Record Key: 4ca622ec-7822-4b51-bfd1-3af8e4886fab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015