FDA.reportPublic FDA data

N/A

Primary DI
16974594960099
Brand
N/A
Company
HBH BIOTECHNOLOGY LIMITED
Model
12ml
Device description
Test tube with test tube plug for reagent storage
Published
2025-03-01
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
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974594960096PackageGS1125In Commercial Distribution
16974594960099PrimaryGS10
06974594960092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697459496009626974594960096
1697459496009916974594960099
06974594960092069745949600926974594960092

GMDN Terms#

Term, Definition table
TermDefinition
Disposable vacuum tubingA sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.

Regulatory Flags#

DUNS number
404071076
Device count
4
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974594960051N/A5ml2025-03-01
16974594960068N/A8ml2025-03-01
16974594960082N/A11ml2025-03-01
16974594960105N/A15ml2025-03-01
16974594960112N/A15ml2025-03-01
16974594960129N/A20ml2025-03-01
16974594960136N/A22ml2025-03-01
16974594960143N/A30ml2025-03-01
16974594960150N/A40ml2025-03-01
16974594960167N/A50ml2025-03-01
16974594960174N/A60ml2025-03-01
16974594960181N/A7ml2025-03-01
16974594960198N/A10ml2025-03-01
16974594960204N/A13ml2025-03-01
16974594960211N/A15ml2025-03-01
16974594960228N/A15ml2025-03-01
16974594960235N/A20ml2025-03-01
16974594960242N/A30ml2025-03-01
16974594960259N/A40ml2025-03-01
16974594960266N/A50ml2025-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850024924109Labcorp Comfort DrawMEDTOX DIAGNOSTICS, INC.KST2026-05-22
H671ABCTD0ABC TinyDrawUTAH MEDICAL PRODUCTS, INC.KST2025-09-18
00850033131116Enhanced HARegenlab USA LLCKST2025-08-29
00810185250509TherapakTherapak LLCKST2025-08-11
00810185250516TherapakTherapak LLCKST2025-08-11
04719875918100Transcend Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-08-07
20193489189664MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
30193489189661MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
10810100050457KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050587KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172676KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050078KBMEDKB Medical (group), Inc.KST2025-05-21
00850016172013KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050075KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050450KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050580KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172010KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050454KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050584KBMEDKB Medical (group), Inc.KST2025-05-21
20850016172673KBMEDKB Medical (group), Inc.KST2025-05-21
04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
04719875918094Virtue Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
10888277415461MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
20888277415468MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974481839125Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
06974481839142Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974594960051N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960068N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960082N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01