UDI device identifier

t:slim X2 5.0 Insulin Pump 1000911

UDI device identifier 00853052007318 · Tandem Diabetes Care, Inc.

Key facts

Primary DI 00853052007318
Brand name t:slim X2 5.0 Insulin Pump
Version or model 1000911
Company Tandem Diabetes Care, Inc.
DUNS number 827900809
Product code OYC
GMDN term Ambulatory insulin infusion pump/blood glucose analyser system
Premarket submission P140015
Device class Class III
Single use No
Packaged sterile No
Implantable No
Publish date Aug 28, 2017
Version date May 4, 2023
Description t:slim X2 5.0 Insulin Pump, Refurbished

At a glance

  • 1,000+ MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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