FDA.reportPublic FDA data

KBMED

Primary DI
00850016172365
Brand
KBMED
Company
KB Medical (group), Inc.
Model
SBCN21-1H
Device description
"Safety blood collection set with pre-attached holder, 21G*3/4"" with 12"" tubing, case of 200pcs"
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192681000Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)Jiangsu Kangbao Medical Equipment Co., Ltd.2020-07-28FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016172365PrimaryGS10
00850016172341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016172365008500161723658500161723650850016172365
00850016172341008500161723418500161723410850016172341

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
105002071
Device count
200
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
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
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23
10850074089114SurgycoSurgyco LLCJKA2025-12-23
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275666McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275697McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275727McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275758McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275789McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14