FDA.reportPublic FDA data

Manifold

Primary DI
06971162812081
Brand
Manifold
Company
Tianck Medical Co., Ltd.
Model
M-02
Catalog number
121002
Device description
Right off 500PSI
Published
2023-02-06
Public version status
Update
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
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971162812088PackageGS125In Commercial Distribution
26971162812085PackageGS14In Commercial Distribution
06971162812081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697116281208816971162812088
2697116281208526971162812085
06971162812081069711628120816971162812081

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418642903
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936841212620Balloon Inflation DeviceBT-30 (30mL) -DG2025-11-12
06936841236329Balloon Inflation DeviceBT-30 (25mL) -DG1000022025-11-12
06971162817789Balloon inflation deviceGTHV1020032024-08-02
06971162818076Puncture needle18G2710012023-05-17
06936841208326Connecting Tube1200PSI 3.81*60CM0430132023-02-07
06936841201976Balloon inflation deviceATHV1030032023-05-18
06936841208128Connecting Tube500PSI 3.05*150CM0420102023-05-18
16936841201973Balloon inflation deviceATHV1030032023-05-18
16936841208125Connecting Tube500PSI 3.05*150CM0420102023-05-18
06971162811817Closed suction catheter12F2210042023-02-06
06936841208098IV cannula II-B-18G1750052023-02-06
06936841209187Suction tube12F2210042023-02-06
06971162810971Radial artery closure bandTB-011910012023-02-06
06971162812098ManifoldM-031210032023-02-06
06971162819707Balloon inflation deviceAT25ML1030022023-02-06
06971162819738Balloon inflation deviceBT25ML1040022023-02-06
06936841200092Radial artery closure bandTB-03S1910052023-03-21
06936841200122Radial artery closure bandTB-03M1910042023-03-21
06936841201037Balloon inflation deviceBT401040042023-02-06
06971162817437Balloon inflation deviceGT20ML1020012023-02-06

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Primary DI, Brand, Company table
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