t:slim X2 Insulin Pump with Control-IQ - t:slim X2 Insulin Pump with Control-IQ, 7.6.x, - TANDEM DIABETES CARE, INC.

Duns Number:827900809

Device Description: t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Replacement

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More Product Details

Catalog Number

1010010

Brand Name

t:slim X2 Insulin Pump with Control-IQ

Version/Model Number

1009642

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Device Record Status

Public Device Record Key

847b1cd0-cc60-41de-97f0-9a465bf7ec27

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TANDEM DIABETES CARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35
3 A medical device with high risk that requires premarket approval 16