FDA.reportPublic FDA data

KBMED

Primary DI
00850016172372
Brand
KBMED
Company
KB Medical (group), Inc.
Model
SBCN23-1H
Device description
"Safety blood collection set with pre-attached holder, 23G*3/4"" with 12"" tubing"
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
PNREnteral Syringes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182649000
K232881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182649000Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd.2018-11-09PNR
K232881000Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle HolderJiangsu Kangbao Medical Equipment Co., Ltd.2023-12-22JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016172389PrimaryGS10
00850016172372Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016172389008500161723898500161723890850016172389
00850016172372008500161723728500161723720850016172372

GMDN Terms#

Term, Definition table
TermDefinition
Oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105002071
Device count
1
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
10192253007435MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007725MonojectCardinal Health 200, LLCPNR2026-02-19
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
10850053289672SurgycoSurgyco LLCPNR2025-12-11
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14