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Device Explorer · FDA GUDID · GMDN 13100

Intravenous pressure infusor, manual, reusable

A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion ba

US‑registered devices181in commercial distribution
Companies23labelers on GUDID
Single‑use50%of device records
Sterile1%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Statcorp Medical5430%
Ningbo Albert Novosino Co.,Ltd.169%
Vbm Medizintechnik Gmbh169%
Airlife127%
Prestige Ameritech, Ltd.106%
Salter Labs95%
Ethox Medical, Llc95%
Transparent Supply Solutions Ltd.84%

Top labelers

CompanyDevicesShare
Statcorp Medical5430%
Ningbo Albert Novosino Co.,Ltd.169%
Vbm Medizintechnik Gmbh169%
Airlife127%
Prestige Ameritech, Ltd.106%
Salter Labs95%
Ethox Medical, Llc95%
Transparent Supply Solutions Ltd.84%
Merit Medical Systems, Inc.63%
Icu Medical, Inc.63%
Concordance Healthcare Solutions Llc53%
Unimed Medical Supplies, Inc.42%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

/ClarifloBieglerUnimedMed-linkJBCDispo Infusormetpak 5000 ml, latex freemetpak 3000 ml, latex freeMerit Medical®Pressure InfuserCuraplexPremierProHCS3M™ Ranger™ACE

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

FDA product codes

CodeNameDevices
KZDINFUSOR, PRESSURE, FOR I.V. BAGS207
KZDInfusor, Pressure, For I.V. Bags126

GMDN & GCC registration

  • GMDN code 13100 · non‑implantable
  • Single‑use 50% · sterile 1% · Rx‑only 76% · 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) · 70

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

How many intravenous pressure infusor, manual, reusable products are registered in the US?

181 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intravenous pressure infusor, manual, reusable", from 23 companies. The largest labeler is Statcorp Medical with 30% of records.

Which FDA product codes apply?

KZD (INFUSOR, PRESSURE, FOR I.V. BAGS), KZD (Infusor, Pressure, For I.V. Bags)

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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