HemoCue Safety Lancet

GUDID 84580505780659

Box of 200 Sterile Single-Use Lancing Device 23 Gauge

ASAHI POLYSLIDER COMPANY,LIMITED

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID84580505780659
NIH Device Record Key3d9248b6-f17b-4e78-a41e-5519c105bbed
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoCue Safety Lancet
Version Model Number130148
Company DUNS718296825
Company NameASAHI POLYSLIDER COMPANY,LIMITED
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS104580505780462 [Primary]
GS184580505780659 [Unit of Use]

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

Devices Manufactured by ASAHI POLYSLIDER COMPANY,LIMITED

80812608030275 - CAPIJECT SAFETY LANCET2023-08-09 Box of 200 Sterile Single-Use Lancing Device Blade 1.0
50389701009204 - CAPIJECT SAFETY LANCET2023-08-09 Box of 200 Sterile Single-Use Lancing Device Blade 1.5
50389701009211 - CAPIJECT SAFETY LANCET2023-08-09 Box of 200 Sterile Single-Use Lancing Device Blade 2.0
50389701009228 - CAPIJECT SAFETY LANCET2023-08-09 Box of 200 Sterile Single-Use Lancing Device Needle 23G
50389701009235 - CAPIJECT SAFETY LANCET2023-08-09 Box of 200 Sterile Single-Use Lancing Device Needle 28G
84580505780659 - HemoCue Safety Lancet2022-12-08Box of 200 Sterile Single-Use Lancing Device 23 Gauge
84580505780659 - HemoCue Safety Lancet2022-12-08 Box of 200 Sterile Single-Use Lancing Device 23 Gauge
20812608030266 - OneTouch Delica Safety2022-12-05 Box of 200 Sterile Single-Use Lancing Device 30 Gauge
00812608030149 - OneTouch Delica Plus Lancet2022-09-28 Box of 30 Sterile Lancets 30 Gauge

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.