Autokeeper

Primary DI
18809445831502
Brand
Autokeeper
Company
MEDEXEL CO.,LTD.
Model
Safety Pen Needle 34G x 4mm 100PCS
Device description
Autokeeper® Safety Pen Needles are single use, sterile, medical devices designed to be used in conjunction with insulin pen injectors. Pen needles are used by consumers, caregivers and health care professionals. They are offered in six gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm and 8mm). This device is sterile (EO gas sterilization). Additionally, the attached safety shield automatically locks in place and is intended to help reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. This device is assembly consists of Sterile cap, Needle cap, Middle cap, Spring, Needle, Safety shield, hub and sterile paper.
Published
2020-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
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
K172095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172095000AutokeeperMedexel Co.,Ltd2018-07-24FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809445831502PackageGS110In Commercial Distribution
28809445831509PackageGS14In Commercial Distribution
08809445831505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880944583150218809445831502
2880944583150928809445831509
08809445831505088094458315058809445831505

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
Needle Gauge29Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689719789
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809445833363Topfine Insulin Syringe 29Gx5mm 0.5ml2026-04-23
08809445833370Topfine Insulin Syringe 30Gx5mm 0.5ml2026-04-23
08809445833387Topfine Insulin Syringe 31Gx5mm 0.5ml2026-04-23
08809445833394Topfine Insulin Syringe 28Gx8mm 0.5ml2026-04-23
08809445833400Topfine Insulin Syringe 29Gx8mm 0.5ml2026-04-23
08809445833417Topfine Insulin Syringe 30Gx8mm 0.5ml2026-04-23
08809445833424Topfine Insulin Syringe 31Gx8mm 0.5ml2026-04-23
08809445833431Topfine Insulin Syringe 28Gx12.7mm 0.5ml2026-04-23
08809445833448Topfine Insulin Syringe 29Gx12.7mm 0.5ml2026-04-23
08809445833455Topfine Insulin Syringe 30Gx12.7mm 0.5ml2026-04-23
08809445833462Topfine Insulin Syringe 31Gx12.7mm 0.5ml2026-04-23
08809445833608Topfine Insulin Syringe 29Gx5mm 1.0ml2026-04-23
08809445833615Topfine Insulin Syringe 30Gx5mm 1.0ml2026-04-23
08809445833622Topfine Insulin Syringe 31Gx5mm 1.0ml2026-04-23
08809445833639Topfine Insulin Syringe 28Gx8mm 1.0ml2026-04-23
08809445833646Topfine Insulin Syringe 29Gx8mm 1.0ml2026-04-23
08809445833653Topfine Insulin Syringe 30Gx8mm 1.0ml2026-04-23
08809445833660Topfine Insulin Syringe 31Gx8mm 1.0ml2026-04-23
08809445833677Topfine Insulin Syringe 29Gx12.7mm 1.0ml2026-04-23
08809445833684Topfine Insulin Syringe 28Gx12.7mm 1.0ml2026-04-23

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