Insulin Pen Needle

GUDID 06949236200478

Berpu Medical Technology Co.,Ltd

Autoinjector needle
Primary Device ID06949236200478
NIH Device Record Keyb0255b62-2439-42f0-9499-fa10d0ab13c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsulin Pen Needle
Version Model Number0.30×8mm
Company DUNS529239746
Company NameBerpu Medical Technology Co.,Ltd
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106949236200119 [Primary]
GS106949236200294 [Package]
Contains: 06949236200119
Package: [100 Units]
In Commercial Distribution
GS106949236200478 [Package]
Contains: 06949236200294
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-20
Device Publish Date2016-09-15

On-Brand Devices [Insulin Pen Needle]

069492362005390.33×12mm
069492362005220.33×8mm
069492362005150.33×6mm
069492362005080.33×5mm
069492362004920.30×12mm
069492362004850.30×10mm
069492362004780.30×8mm
069492362004610.30*6mm
069492362004540.30×5mm
069492362004470.25×12mm
069492362004300.25×8mm
069492362004230.25×6mm
069492362004160.25×5mm
069492362004090.25×4mm
069492362003930.23×8mm
069492362003860.23×6mm
069492362003790.23×5mm
069492362003620.23×4mm

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