FDA.reportPublic FDA data

Radial artery closure band

Primary DI
06971162810971
Brand
Radial artery closure band
Company
Tianck Medical Co., Ltd.
Model
TB-01
Catalog number
191001
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
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971162810978PackageGS125In Commercial Distribution
26971162810975PackageGS18In Commercial Distribution
06971162810971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697116281097816971162810978
2697116281097526971162810975
06971162810971069711628109716971162810971

GMDN Terms#

Term, Definition table
TermDefinition
Radial artery compression deviceA device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). 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
06971162812081ManifoldM-021210022023-02-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16