HealthMart/UltiCare

GUDID 00357515710130

5mm Pen Needle UltiGuard

ULTIMED, INC.

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle
Primary Device ID00357515710130
NIH Device Record Key5a033dbb-2208-4bbe-9231-8ce9494ef2a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthMart/UltiCare
Version Model Number1543057
Company DUNS024723541
Company NameULTIMED, INC.
Device Count100
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS100357515710130 [Unit of Use]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]
GS120357515430575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
FMINeedle, Hypodermic, Single Lumen
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 Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by ULTIMED, INC.

00357515710130 - HealthMart/UltiCare2020-06-235mm Pen Needle UltiGuard
00357515710130 - HealthMart/UltiCare2020-06-23 5mm Pen Needle UltiGuard
00357515710031 - Simpli2020-05-11 4mm 32G pen needle box 90ct
30357515745430 - Simpli2020-05-11 4mm 32G Pen Needle Box 90ct
30357515745522 - Simpli2020-05-11 5mm 31G Pen Needle box 120
30357515745539 - Simpli2020-05-11 5mm 31G Pen Needle box 90ct
30357515745621 - Simpli2020-05-11 6mm 32G Pen Needle Box 120
30357515745638 - Simpli2020-05-11 6mm 32G Pen Needle Box 90ct
30357515745829 - Simpli2020-05-11 8mm 31G Pen Needle Box 120

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.