AccessGUDID - DEVICE: CBCII ConstaVac (00855168008258)

GUDID

Device Identifier (DI) Information

Brand Name: CBCII ConstaVac
Version or Model: 225-028-914
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 225-028-914
Company Name: 3T MEDICAL SYSTEMS, INC.

Primary DI Number: 00855168008258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112462671 *Terms of Use

Device Description: CBCII with Quick Disconnect, 1/8” Round PVC Drain & Trocar

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47977	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.	Obsolete	false

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 4a9207f0-2629-4efd-ab4a-47cafe436d95
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: October 31, 2018