FDA.reportPublic FDA data

KBMED

Primary DI
10810100050099
Brand
KBMED
Company
KB Medical (group), Inc.
Model
SN1B-2125
Device description
"Safety Needle, 21Gx1"", pack of 100pcs"
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221247000Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable NeedleJiangsu Kangbao Medical Equipment Co., Ltd.2022-11-01MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810100050099PrimaryGS10
00810100050092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010005009910810100050099
00810100050092008101000500928101000500920810100050092

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Regulatory Flags#

DUNS number
105002071
Device count
100
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

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Primary DI, Brand, Company table
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