FDA.reportPublic FDA data

3/8'' x 1/4'' Reducer Connector w/L.L.

Primary DI
36641670004490
Brand
3/8'' x 1/4'' Reducer Connector w/L.L.
Company
Cardiomed Supplies Inc
Model
2.8
Catalog number
C-676
Device description
This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.
Published
2020-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833112000TUBING FOR CARDIOPULMONARY BYPASSCardio Med Supplies, Inc.1983-11-28DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670004490PrimaryGS10
16641670004489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167000449036641670004490
1664167000448916641670004489

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, single-use, sterileA sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.

Regulatory Flags#

DUNS number
240623124
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36641670001314Adult Heart Cooling Jacket2.417-2602021-04-21
36641670001338Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
36641670001352Pediatric Heart Cooling Jacket2.017-2622021-04-21
36641670011528rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
36641670019241Drop-It™ Quick Release Needle Holders1.145502021-04-21
16641670001303Adult Heart Cooling Jacket2.417-2602021-04-21
16641670001327Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
16641670001341Pediatric Heart Cooling Jacket2.017-2622021-04-21
16641670011517rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670019230Drop-It™ Quick Release Needle Holders1.145502021-04-21
366416700041793/8'' x 1/4'' x 3/8'' Y Connector2.9C-6602020-12-02
366416700041931/2'' x 3/8'' x 3/8'' Y Connector2.8C-6612020-12-02
366416700042163/8'' x 1/4'' x 1/4'' Y Connector2.0C-6622020-12-02
366416700042301/2'' x 3/8'' x 1/2'' Y Connector2.4C-6632020-12-02
366416700042541/4'' Y Connector w/L.L.2.6C-6642020-12-02
366416700042783/8'' Y Connector w/L.L.2.6C-6652020-12-02
366416700042921/2'' Y Connector w/L.L.1.4C-6662020-12-02
366416700043153/16'' Y Connector w/L.L.1.5C-6672020-12-02
366416700043393/8'' x 1/4'' x 3/8'' Y Connector w/L.L.1.3C-6682020-12-02
366416700043531/2'' x 3/8'' x 3/8'' Y Connector w/L.L.1.6C-6692020-12-02

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Primary DI, Brand, Company table
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08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
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