t:slim G4 Cartridge 2 Pack

FDA UDI

Class III (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name: t:slim G4 Cartridge 2 Pack FDA UDI
Generic Name: Ambulatory insulin infusion pump reservoir FDA UDI
Device Name: The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions. FDA UDI
Model / Reference: 007527 FDA UDI
Description: The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852162004422 FDA UDI
PMA Number: P140015 FDA UDI
FDA Product Code: OYC FDA UDI
GMDN Term: Ambulatory insulin infusion pump reservoir FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Total Volume — 3 Milliliter FDA UDI

Category: Ambulatory insulin infusion pump reservoir

The t:slim G4 Cartridge 2 Pack is the ultimate insulin pump for ambulatory diabetic patients. This single-use, sterile device combines advanced continuous glucose monitoring (CGM) technology with convenient CGM graph and trend information on a single color touch screen. It features a user-friendly design, ensuring ease of use for both beginners and frequent users. The device also includes built-in sensors to track glucose levels and alert you when your values are outside the target range. With its compact size and long battery life, this pump is perfect for those who want the freedom to manage their diabetes on-the-go.

Similar devices

Also classified as Ambulatory insulin infusion pump reservoir.

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MiniMed Reservoir — MEDTRONIC MINIMED, INC. · Class II
MiniMed™ Reservoir — MEDTRONIC MINIMED, INC. · Class III
DANA Diabecare — SOOIL DEVELOPMENT CO., LTD · Class II
iLet Insulin Infusion Kit - Inset (32”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
iLet Starter Kit - Contact Detach — Beta Bionics, Inc. · Class II
CeQur Simplicity — Cequr SA · Class II
iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack — Beta Bionics, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Tandem Diabetes Care, Inc.

Sources (1)

FDA UDI d3c0ac5d-cce0-4898-9513-5f36b91e1a26 37 fields · synced Jul 13, 2026