iLet Flex

GUDID 05705244026865

ilet Flex, 6mm, 46cm 10 pack

Unomedical A/S

Electric infusion pump administration set, single-use
Primary Device ID05705244026865
NIH Device Record Key5f1355ff-8bd7-4db5-90d8-9adaf0a70cd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameiLet Flex
Version Model NumberFG000063-02
Company DUNS306032491
Company NameUnomedical A/S
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com
Phone+18004228811
Emailcic12@convatec.com

Device Dimensions

Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter
Length46 Centimeter
Angle90 degree
Depth6 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in high humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS105705244026858 [Package]
Contains: 05705244026872
Package: [10 Units]
In Commercial Distribution
GS105705244026865 [Package]
Contains: 05705244026858
Package: [80 Units]
In Commercial Distribution
GS105705244026872 [Primary]

FDA Product Code

FPASet, administration, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-14

On-Brand Devices [iLet Flex]

05705244027183ilet Flex, 9mm, 80cm 2 pack
05705244027152ilet Flex, 9mm, 60cm 2 pack
05705244027138ilet Flex, 9mm, 46cm 2 pack
05705244027107ilet Flex, 6mm, 80cm 2pack
05705244027060ilet Flex, 6mm, 60cm 2 pack
05705244027046ilet Flex, 6mm, 46cm 2 pack
05705244027015ilet Flex, 9mm, 80cm 10 pack
05705244026988ilet Flex, 9mm, 60cm 10 pack
05705244026957ilet Flex, 9mm, 46cm 10 pack
05705244026926ilet Flex, 6mm, 80cm 10 pack
05705244026889ilet Flex, 6mm, 60cm 10 pack
05705244026865ilet Flex, 6mm, 46cm 10 pack

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.