Orbit soft O4291OB

GUDID 07613117016821

Orbit soft Infusion Set, 9 mm soft cannula, 105 cm (42") blue tubing / An infusion set for infusion pumps with standard Luer-lock connection and 360°

Ypsomed AG

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use
Primary Device ID07613117016821
NIH Device Record Keyea169b78-6b71-4f74-856b-7e3c214fa3c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrbit soft
Version Model NumberO4291OB
Catalog NumberO4291OB
Company DUNS481742760
Company NameYpsomed AG
Device Count10
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+1(888)775-1997
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com
Phone+1(866)948-5888
Emailinfo@ypsomed.com

Device Dimensions

Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613117016791 [Unit of Use]
GS107613117016814 [Primary]
GS107613117016821 [Package]
Contains: 07613117016814
Package: SHIPPER BOX [10 Units]
In Commercial Distribution

FDA Product Code

FPASet, administration, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by Ypsomed AG

07613117034795 - Penfine Classic Pen Needles2023-06-27 Sterile, single-use, pen needles, 32 Gauge, 4mm (5/32") Length, Extra-thin wall
07613117034825 - Penfine Classic Pen Needles2023-06-27 Sterile, single-use, pen needles, 31 Gauge, 5mm (3/16") Length, Extra-thin wall
07613117034863 - Penfine Classic Pen Needles2023-06-27 Sterile, single-use, pen needles, 32 Gauge, 6mm (1/4") Length, Extra-thin wall
07613117032326 - Clickfine Pen Needles2022-09-02 Sterile, single-use, 6-bevel pen needles, 31 Gauge, 5mm (3/16") Length, Extra-thin wall
07613117026196 - Clickfine AutoProtect2022-05-05 Sterile, single-use, safety pen needle, 31Gauge, 5mm (3/16”) Length
07613117031299 - Clickfine pen needles2021-11-09 sterile, single-use, 6-bevel pen needles, 31Gauge, 8mm (5/16") length, extra thin wall
07613117017606 - Soft-Release-Micro2020-09-23 Soft-Release-Micro Infusion Set, 5.5 mm steel cannula, 30 cm (12") blue tubing. / Infusion set with a steel cannula designed to
07613117017613 - Soft-Release-Micro2020-09-23 Soft-Release-Micro Infusion Set, 8.5 mm steel cannula, 30 cm (12") blue tubing. / Infusion set with a steel cannula designed to

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