FDA.reportPublic FDA data

SmartTap™ Paracentesis Drainage Bag, 4L

Primary DI
36641670005589
Brand
SmartTap™ Paracentesis Drainage Bag, 4L
Company
Cardiomed Supplies Inc
Model
3.8
Catalog number
CM-0020
Published
2020-11-27
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
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670005589PrimaryGS10
16641670005578Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167000558936641670005589
1664167000557816641670005578

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal fistula drainage supplementary bagA plastic pouch intended to be connected to an abdominal fistula drainage set (not included) to supplement the set’s capacity for fluid or purulent material collection and removal during drainage/healing of a large fistula or wound; it may in addition be connected to an intestinal ostomy bag. It is not a primary collection device and is not intended to be attached directly to the patient. This is a single-use device.

Regulatory Flags#

DUNS number
240623124
Device count
25
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118607346ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00840118611930ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00610075096459HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
00610075096558HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
00610075105618HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096453HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096552HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075105612HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
10080196028863MEDLINEMEDLINE INDUSTRIES, INC.EYZ2022-01-16
36641670005626SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
16641670005578SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
16641670005615SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
00810050241137N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
00810050242202N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
05055788767459EZ-Flow Catheter ValveFLEXICARE MEDICAL LIMITEDEYZ2020-03-25
20686864042956AMD-RITMEDAMD Medicom IncEYZ2019-01-24
20686864042963AMD-RITMEDAMD Medicom IncEYZ2019-01-24
10884521003446DoverCardinal Health, Inc.EYZ2018-06-27
10884521003453DoverCardinal Health, Inc.EYZ2018-06-27
20884521003443DoverCardinal Health, Inc.EYZ2018-06-27
20884521003450DoverCardinal Health, Inc.EYZ2018-06-27
10080196028856MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183012MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183401MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183418MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183531MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196028857MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183013MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183402MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14