MeritPoint

GUDID 10853620005170

Merit Pharmaceutical

Insulin syringe/needle, basic
Primary Device ID10853620005170
NIH Device Record Key4d13b88a-a3cc-4334-b83c-8cc536801b1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeritPoint
Version Model Number044453304000
Company DUNS093370369
Company NameMerit Pharmaceutical
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com
Phone(323) 227-4831
Emailsolutions@meritpharm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853620005173 [Primary]
GS110853620005170 [Package]
Contains: 00853620005173
Package: [100 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-01
Device Publish Date2019-01-01

Devices Manufactured by Merit Pharmaceutical

20853620005337 - IV Administration Set 60 Drop2020-05-04
10853620005439 - Needleless Neutral Valve2020-05-04
20853620005429 - IV Catheter Safety Winged 24G x 3/42020-05-01
20853620005207 - IV Set With In-Line Filter2019-12-11
20853620005214 - IV Set2019-12-11
20853620005276 - IV Administration Set2019-12-11
00853620005302 - Pressure Infuser 1000mL2019-12-11
20853620005313 - IV Administration Set Needlefree2019-12-11

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