Unifine Pentips - 6mm x 32G AN3595

GUDID 00384703595033

For use with injectors for the subcutaneous injection of approved drugs, including insulin.

OWEN MUMFORD USA INCORPORATED

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 Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle
Primary Device ID00384703595033
NIH Device Record Key29d87184-341b-4ebf-8031-aff5473c6aa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 6mm x 32G
Version Model NumberAN3595
Catalog NumberAN3595
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Length6 Millimeter
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703595002 [Unit of Use]
GS100384703595019 [Primary]
GS100384703595026 [Package]
Contains: 00384703595019
Package: Sleeve [10 Units]
In Commercial Distribution
GS100384703595033 [Package]
Contains: 00384703595026
Package: Case [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-05
Device Publish Date2018-10-03

Devices Manufactured by OWEN MUMFORD USA INCORPORATED

00761059354024 - Unifine Pentips2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G
00761059352921 - Unifine Pentips2024-01-30 Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G
00384707001035 - Unistik VacuFlip2023-10-16 Unistik VacFlip, 20G Safety Needle 1"
00384707102039 - Unistik VacuFlip2023-10-16 Unistik VacuFlip, 21G safety needle 1" with holder
00384707117033 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing
00384707122037 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing
00384707312032 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing
00384707317037 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing

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