Disposable Insulin Syringe

GUDID 06949236201949

Berpu Medical Technology Co.,Ltd

Insulin syringe/needle, safety
Primary Device ID06949236201949
NIH Device Record Key55c02e93-04ec-440b-834b-66991a9e0038
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Insulin Syringe
Version Model NumberU-100 1ML 29G×8mm No protective end top
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
GS106949236200904 [Primary]
GS106949236201420 [Package]
Contains: 06949236200904
Package: [100 Units]
In Commercial Distribution
GS106949236201949 [Package]
Contains: 06949236200904
Package: [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

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 Date2017-03-31

On-Brand Devices [Disposable Insulin Syringe]

06949236202090U-100 1ML 31G×8mm Protective end top
06949236202083U-100 1ML 31G×8mm No protective end top
06949236202076U-100 1ML 31G×6mm Protective end top
06949236202069U-100 1ML 31G×6mm No protective end top
06949236202052U-100 1ML 31G×5mm Protective end top
06949236202045U-100 1ML 31G×5mm No protective end top
06949236202038U-100 1ML 30G×12mm Protective end top
06949236202021U-100 1ML 30G×12mm No protective end top
06949236202014U-100 1ML 30G×8mm Protective end top
06949236202007U-100 1ML 30G×8mm No protective end top
06949236201994U-100 1ML 30G×6mm Protective end top
06949236201987U-100 1ML 30G×6mm No protective end top
06949236201970U-100 1ML 29G×12mm Protective end top
06949236201963U-100 1ML 29G×12mm No protective end top
06949236201956U-100 1ML 29G×8mm Protective end top
06949236201949U-100 1ML 29G×8mm No protective end top
06949236201932U-100 1ML 28G×12mm Protective end top
06949236201925U-100 1ML 28G×12mm No protective end top
06949236201918U-100 1ML 27G×12mm Protective end top
06949236201901U-100 1ML 27G×12mm No protective end top
06949236201895U-100 0.5ML 31G×8mm Protective end top
06949236201888U-100 0.5ML 31G×8mm No protective end top
06949236201871U-100 0.5ML 31G×6mm Protective end top
06949236201864U-100 0.5ML 31G×6mm No protective end top
06949236201857U-100 0.5ML 31G×5mm Protective end top
06949236201840U-100 0.5ML 31G×5mm No protective end top
06949236201833U-100 0.5ML 30G×12mm Protective end top
06949236201826U-100 0.5ML 30G×12mm No protective end top
06949236201819U-100 0.5ML 30G×8mm Protective end top
06949236201802U-100 0.5ML 30G×8mm No protective end top
06949236201796U-100 0.5ML 30G×6mm Protective end top
06949236201789U-100 0.5ML 30G×6mm No protective end top
06949236201772U-100 0.5ML 29G×12mm Protective end top
06949236201765U-100 0.5ML 29G×12mm No protective end top
06949236201758U-100 0.5ML 29G×8mm Protective end top
06949236201741U-100 0.5ML 29G×8mm No protective end top
06949236201734U-100 0.5ML 28G×12mm Protective end top
06949236201727U-100 0.5ML 28G×12mm No protective end top
06949236201710U-100 0.3ML 31G×8mm Protective end top
06949236201703U-100 0.3ML 31G×8mm No protective end top
06949236201697U-100 0.3ML 31G×6mm Protective end top
06949236201680U-100 0.3ML 31G×6mm No protective end top
06949236201673U-100 0.3ML 31G×5mm Protective end top
06949236201666U-100 0.3ML 31G×5mm No protective end top
06949236201659U-100 0.3ML 30G×12mm Protective end top
06949236201642U-100 0.3ML 30G×12mm No protective end top
06949236201635U-100 0.3ML 30G×8mm Protective end top
06949236201628U-100 0.3ML 30G×8mm No protective end top
06949236201611U-100 0.3ML 29G×12mm Protective end top
06949236201604U-100 0.3ML 29G×12mm No protective end top

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