FDA.reportPublic FDA data

Constavac CBC II

Primary DI
00855168008050
Brand
Constavac CBC II
Company
3T MEDICAL SYSTEMS, INC.
Model
225-426-000
Catalog number
225-426-000
Device description
CBCII Conservation Kit with 3/16” Round PVC Wound Drain
Published
2019-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00855168008067PackageGS16In Commercial Distribution
00855168008050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855168008067008551680080678551680080670855168008067
00855168008050008551680080508551680080500855168008050

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
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
112462671
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00855168008043ConstaVac CBC II225-416-000225-416-0002019-05-02
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