Consulting Wallah › Device Explorer › Syringes, needles & infusion › Ambulatory insulin infusion pump reservoir
Device Explorer · FDA GUDID · GMDN 35838

Ambulatory insulin infusion pump reservoir

An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.

US‑registered devices66in commercial distribution
Companies6labelers on GUDID
Single‑use91%of device records
Sterile94%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Tandem Diabetes Care, Inc.4974%
Medtronic Minimed, Inc.69%
Cequr Corporation69%
Beta Bionics, Inc.23%
Sooil Development Co.,Ltd23%
Modular Medical, Inc.12%

Top labelers

CompanyDevicesShare
Tandem Diabetes Care, Inc.4974%
Medtronic Minimed, Inc.69%
Cequr Corporation69%
Beta Bionics, Inc.23%
Sooil Development Co.,Ltd23%
Modular Medical, Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

t:slim Cartridge, t:lock, 10 Packt:flex Cartridge, t:lock, 2 Packt:flex Cartridge, t:lock, 10 Packt:slim Cartridge, t:lock, 2 Packt:slim X2 Cartridge, t:lock, 2 Packt:slim X2 Cartridge, t:lock, 10 Packt:flex Cartridge 2 Packt:slim Cartridge 2 Packt:flex Insulin Pump, Reconditionedt:flex Insulin Pump, Replacementt:flex Insulin Pump, Replacement, Refurbishedt:slim G4 Cartridge 2 Packt:slim G4 Cartridge 10 Packt:flex Cartridge 10 Packt:flex Insulin Pumpt:slim Cartridge 10 Pack

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
QFGAlternate Controller Enabled Insulin Infusion Pump35
LZGPump, Infusion, Insulin23
FPASet, Administration, Intravascular17
QJIInteroperable Automated Glycemic Controller10
FRNPump, infusion6
OPPPump, Infusion, Insulin Bolus6

GMDN & GCC registration

  • GMDN code 35838 · non‑implantable
  • Single‑use 91% · sterile 94% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 21Weight (Gram) · 1Outer Diameter (Millimeter) · 1Needle Gauge (Gauge) · 1

Use these as the dimensions to specify in a tender line.

How many ambulatory insulin infusion pump reservoir products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ambulatory insulin infusion pump reservoir", from 6 companies. The largest labeler is Tandem Diabetes Care, Inc. with 74% of records.

Which FDA product codes apply?

QFG (Alternate Controller Enabled Insulin Infusion Pump), LZG (Pump, Infusion, Insulin), FPA (Set, Administration, Intravascular), QJI (Interoperable Automated Glycemic Controller)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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