FDA.reportPublic FDA data

ConstaVac CBC II

Primary DI
00855168008043
Brand
ConstaVac CBC II
Company
3T MEDICAL SYSTEMS, INC.
Model
225-416-000
Catalog number
225-416-000
Device description
ConstaVac CBCII Conservation Kit with 1/4” Round PVC Wound Drain
Published
2019-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CACApparatus, Autotransfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970714000STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)Stryker Instruments1997-12-16CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855168008043PackageGS16In Commercial Distribution
00855168008036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855168008043008551680080438551680080430855168008043
00855168008036008551680080368551680080360855168008036

GMDN Terms#

Term, Definition table
TermDefinition
Whole-blood-recovery autotransfusion system, poweredAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7345259580sales@3tmedical.com

Regulatory Flags#

DUNS number
112462671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855168008579Ambulating Bulb225-028-852225-028-8522021-04-02
00855168008111Constavac CBC II225-028-514225-028-5142019-08-20
00855168008135Constavac CBC II225-028-516225-028-5162019-08-07
00855168008159Constavac CBC II225-028-526225-028-5262019-05-23
00855168008333Constavac CBC II225-028-085S1225-028-085S12019-04-25
00855168008050Constavac CBC II225-426-000225-426-0002019-11-08
00855168008067Constavac CBC II225-426-000225-426-0002019-11-08
00855168008210Constavac CBC II225-028-626225-028-6262019-10-08
00855168008227Constavac CBC II225-028-626225-028-6262019-10-08
00855168008128Constavac CBC II225-028-514225-028-5142019-08-20
00855168008142Constavac CBC II225-028-516225-028-5162019-08-07
00855168008647Constavac CBC III225-414-000W225-414-000W2019-03-01
00855168008661Constavac CBC III225-426-000W225-426-000W2019-03-01
00855168008630Constavac CBC III225-414-000W225-414-000W2019-03-01
00855168008654Constavac CBC III225-426-000W225-426-000W2019-03-01
00855168008166Constavac CBC II225-028-526225-028-5262019-05-23
00855168008036ConstaVac CBC II225-416-000225-416-0002019-05-02
00855168008234ConstaVac CBC II225-028-085225-028-0852019-05-02
00855168008296ConstaVac CBC II 225-028-926225-028-9262019-05-02
00855168008241ConstaVac CBC II225-028-085225-028-0852019-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937230PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937308PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937315PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704912206PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704912213PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704911797PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911803PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911865PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
08033178113700XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113939XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113946XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113953XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113984XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLCAC2024-12-20