FDA.reportPublic FDA data

KBMED

Primary DI
10810100050617
Brand
KBMED
Company
KB Medical (group), Inc.
Model
CTPS12
Device description
CENTRIFUGE TUBE WITHOUT CAP, 12ML PS, PACK OF 200
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810100050617PackageGS112In Commercial Distribution
00810100050610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010005061710810100050617
00810100050610008101000506108101000506100810100050610

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube IVDA tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105002071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810100051270KBMEDSCB10502025-05-23
00810100051280KBMEDPT101002025-05-23
00810100051273KBMEDSCB10502025-05-23
10810100051287KBMEDPT101002025-05-23
20810100051277KBMEDSCB10502025-05-23
00810100050269KBMEDTT-PPS102025-05-22
00810100050283KBMEDTT-PS12752025-05-22
00810100050306KBMEDCAP-TT12752025-05-22
00810100050313KBMEDLC30S2025-05-22
00810100050320KBMEDLC30M2025-05-22
00810100050337KBMEDLC30L2025-05-22
00810100050344KBMEDLC30XL2025-05-22
00810100050429KBMEDCB1502025-05-22
00810100050511KBMEDCTPS152025-05-22
00810100050528KBMEDCTPP152025-05-22
00810100050535KBMEDCTPP15-C2025-05-22
00810100050542KBMEDTT-PP12752025-05-22
00810100050559KBMEDCAP-TT1275P2025-05-22
00810100050566KBMEDUC90-B2B2025-05-22
00810100050603KBMEDTT-GB12752025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-23
10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22