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Device Explorer · FDA GUDID · GMDN 35127

Intravenous administration bag/bottle

An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers an

US‑registered devices287in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Metrix Company, The6322%
B. Braun Medical Inc.4415%
Valmed Srl3010%
Acta Medical Llc238%
Douglas Medical Products, Inc.217%
Pisa Biopharm Inc.207%
Baxter Healthcare Corporation186%
Gvs Spa145%

Top labelers

CompanyDevicesShare
Metrix Company, The6322%
B. Braun Medical Inc.4415%
Valmed Srl3010%
Acta Medical Llc238%
Douglas Medical Products, Inc.217%
Pisa Biopharm Inc.207%
Baxter Healthcare Corporation186%
Gvs Spa145%
Epic International(Thailand) Company Limited135%
Tranzonic Companies, The93%
International Filter Products, Inc.83%
Hometa, Inc.72%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable Infusion Bag for Parenteral NutritionAPEX™B.BRAUNPINNACLE®APEX®International Filter Products, doing business asEmpty IV Bag 1000mLActa MedicalRight Way MedicalDJF MedHometaPiSA BioPharmMediBagSECURE®CORMIXNA

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

FDA product codes

CodeNameDevices
KPEContainer, I.V.259
KPECONTAINER, I.V.57
LHISet, i.V. Fluid transfer9
KNTTubes, Gastrointestinal (And Accessories)4
FPBFilter, Infusion Line3
NEPSystem/Device, Pharmacy Compounding3

GMDN & GCC registration

  • GMDN code 35127 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 91% · 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) · 102

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

How many intravenous administration bag/bottle products are registered in the US?

287 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intravenous administration bag/bottle", from 19 companies. The largest labeler is Metrix Company, The with 22% of records.

Which FDA product codes apply?

KPE (Container, I.V.), KPE (CONTAINER, I.V.), LHI (Set, i.V. Fluid transfer), KNT (Tubes, Gastrointestinal (And Accessories))

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.

How do I get quotes?

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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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