Constavac CBC III 225-414-000W

GUDID 00855168008630

ConstaVac CBCIII Conservation Kit with 3.2 mm Round PVC Wound Drain

3T MEDICAL SYSTEMS, INC.

Whole-blood-recovery autotransfusion system, powered
Primary Device ID00855168008630
NIH Device Record Key3eaedbb6-c6d7-41ab-8ac0-189840860a64
Commercial Distribution StatusIn Commercial Distribution
Brand NameConstavac CBC III
Version Model Number225-414-000W
Catalog Number225-414-000W
Company DUNS112462671
Company Name3T MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7345259580
Emailsales@3tmedical.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855168008630 [Package]
Contains: 00855168008647
Package: Pack [6 Units]
In Commercial Distribution
GS100855168008647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-16
Device Publish Date2019-03-01

On-Brand Devices [Constavac CBC III]

00855168008654ConstaVac CBCIII Blood Conservation Kit with 4.8 mm Round PVC Wound Drain
00855168008630ConstaVac CBCIII Conservation Kit with 3.2 mm Round PVC Wound Drain

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