contact detach

GUDID 05705244025271

Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

Electric infusion pump administration set, single-use
Primary Device ID05705244025271
NIH Device Record Key70da3a82-0d99-4962-9b44-832e67763d4a
Commercial Distribution StatusIn Commercial Distribution
Brand Namecontact detach
Version Model NumberFG000016-03
Company DUNS306032491
Company NameUnomedical A/S
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter
Angle90 degree
Depth6 Millimeter
Length60 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle

Device Identifiers

Device Issuing AgencyDevice ID
GS105705244025264 [Primary]
GS105705244025271 [Package]
Contains: 05705244025264
Package: Outer Box [200 Units]
In Commercial Distribution
GS105705244025288 [Unit of Use]

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 Number3
Public Version Date2024-04-30
Device Publish Date2022-12-21

Devices Manufactured by Unomedical A/S

05705244026261 - inset™2024-05-10 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244026292 - inset™2024-05-10 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244025271 - contact detach2024-04-30Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244025271 - contact detach2024-04-30 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244025998 - Autosoft™ XC2023-06-21 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244026025 - Autosoft™ XC2023-06-21 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244026056 - Autosoft™ XC2023-06-21 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244023383 - Medtronic Extended2023-06-09 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
05705244023413 - Medtronic Extended2023-06-09 Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

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