Medtronic Extended

GUDID 05705244022690

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 ID	05705244022690
NIH Device Record Key	dd592a4c-7e93-4e50-8803-b3cf56bfa5f5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Medtronic Extended
Version Model Number	MMT-431A
Company DUNS	306032491
Company Name	Unomedical A/S
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05705244022683 [Primary]
GS1	05705244022690 [Package] Contains: 05705244022683 Package: Outer Box [80 Units] In Commercial Distribution
GS1	05705244022706 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210544

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-07-07
Device Publish Date	2022-06-29

On-Brand Devices [Medtronic Extended]

05705244023352	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023321	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023291	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023260	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023239	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023208	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023178	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023147	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023116	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023086	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023055	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023024	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022997	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022966	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022935	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022904	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022874	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022843	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022812	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022782	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022751	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022720	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022690	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244022669	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023598	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023543	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025547	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025516	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025486	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025455	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025424	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025394	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025363	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025332	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023567	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023505	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023475	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023444	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023413	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244023383	Single use infusion set for subcutaneous infusion. The infusion set must be used as described in