DEVICE: Enlite® Serter (00643169246478)

Device Identifier (DI) Information

Enlite® Serter
MMT-7510
In Commercial Distribution

MEDTRONIC MINIMED, INC.
00643169246478
GS1

1
849626338 *Terms of Use
LANCET DEVICE MMT-7510 ENLT SNSRTR US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45449 Injector reset device
A device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CGA GLUCOSE OXIDASE, GLUCOSE
OZO Artificial pancreas device system, threshold suspend
OYC Pump, infusion, insulin, to be used with invasive glucose sensor
MDS Sensor, glucose, invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P120010 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

241c5721-0642-49f0-821a-4b64c8acabe1
July 06, 2018
3
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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