DEVICE: Tandem Mobi Starter Kit (00389152311777)

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Device Record History
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Device Identifier (DI) Information
Tandem Mobi Starter Kit
1013117
In Commercial Distribution

Tandem Diabetes Care, Inc.
00389152311777
GS1

1
827900809 *Terms of Use
with Control-IQ 7.X
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Device Characteristics
MR Unsafe
No
No
No
Yes
No
Yes
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?
64891 Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QFG Alternate Controller Enabled Insulin Infusion Pump
QJI Interoperable Automated Glycemic Controller
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K223213 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c4f7ff60-3507-41f4-8997-98e6240d94b0
April 04, 2024
1
March 27, 2024
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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)

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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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