AccessGUDID - DEVICE: NA (04546540867322)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0225028614
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0225-028-614
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540867322
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: CBCII Double Trocar Kit with 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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: d0914c75-a912-4933-8610-0b9ad602e812
Public Version Date: August 24, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2015