TKMD

Primary DI
16934841570068
Brand
TKMD
Company
Anhui Tiankang Medical Technology Co., Ltd.
Model
TKSN
Device description
The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.
Published
2020-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K191644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191644000TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.2020-08-06FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16934841570068PackageGS1100In Commercial Distribution
66934841570063PackageGS120In Commercial Distribution
06934841570061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693484157006816934841570068
6693484157006366934841570063
06934841570061069348415700616934841570061

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527035248
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06934841570009TKMDTKSN2020-09-16
06934841570016TKMDTKSN2020-11-05
06934841570023TKMDTKSN2020-11-05
06934841570030TKMDTKSN2020-11-12
06934841570047TKMDTKSN2020-11-12
06934841570054TKMDTKSN2020-11-12
06934841570061TKMDTKSN2020-11-12
06934841570078TKMDTKSN2020-11-12
06934841570085TKMDTKSN2020-11-12
06934841570092TKMDTKSN2021-02-04
06934841570108TKMDTKSN2021-02-04
06934841570115TKMDTKSN2021-02-04
06934841570122TKMDTKSN2021-02-04
06934841570139TKMDTKSN2021-02-04
06934841570146TKMDTKSN2021-02-04
06934841570153TKMDTKSN2021-02-04
06934841570160TKMDTKSN2021-02-04
06934841570177TKMDTKSN2021-02-04
06934841570184TKMDTKSN2021-02-04
06934841570191TKMDTKSN2021-02-04

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