DEVICE: t:slim X2 5.0 Insulin Pump (00853052007967)

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Device Record History
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Device Identifier (DI) Information
t:slim X2 5.0 Insulin Pump
1003487
In Commercial Distribution

Tandem Diabetes Care, Inc.
00853052007967
GS1

1
827900809 *Terms of Use
t:slim X2 5.0 Insulin Pump, Replacement
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Device Characteristics
MR Unsafe
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?
51083 Ambulatory insulin infusion pump/blood glucose analyser system
An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P140015 000
P140015 020
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0ecf9c57-c1f0-4a03-8f34-91b3d61fca93
May 04, 2023
2
October 15, 2018
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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
No
No
No CLOSE

Customer Contact

[?]
877-801-6901
TandemCares@tandemdiabetes.com
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