Consulting Wallah › Device Explorer › Syringes, needles & infusion › Intraosseous infusion kit
Device Explorer · FDA GUDID · GMDN 18009

Intraosseous infusion kit

A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly

US‑registered devices155in commercial distribution
Companies15labelers on GUDID
Single‑use97%of device records
Sterile72%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Teleflex Incorporated4227%
Cook Incorporated3120%
Bound Tree Medical, Llc2315%
Zien Medical Technologies, Llc138%
Safeguard Us Operating, Llc96%
Waismed Ltd75%
Ecs Opco 1 Llc64%
Sam Medical Products64%

Top labelers

CompanyDevicesShare
Teleflex Incorporated4227%
Cook Incorporated3120%
Bound Tree Medical, Llc2315%
Zien Medical Technologies, Llc138%
Safeguard Us Operating, Llc96%
Waismed Ltd75%
Ecs Opco 1 Llc64%
Sam Medical Products64%
Bard Access Systems, Inc.53%
Einstein Works, Llc32%
Pyng Medical Corp32%
Integrated Medcraft Llc21%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NIOB.I.G.ShippertTechSAM MedicalFORWARD® Intraosseous Infusion BundleFORWARD IO INFUSION KITNIO NEXT GENERATION IONIO Next Generation IONARNAR KitIntraosseous Infusion NeedlesX-TipDieckmannSur FastCookSussmane-Raszynski

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

FDA product codes

CodeNameDevices
FMINeedle, hypodermic, single lumen86
FMINeedle, Hypodermic, Single Lumen51
OKEPort introducer kit17
LRSI.V. Start Kit11
POQBlood transfusion kit3
FMFSyringe, piston3

GMDN & GCC registration

  • GMDN code 18009 · non‑implantable
  • Single‑use 97% · sterile 72% · Rx‑only 94% · 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

Needle Gauge (Gauge) · 10Length (Millimeter) · 10

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

How many intraosseous infusion kit products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraosseous infusion kit", from 15 companies. The largest labeler is Teleflex Incorporated with 27% of records.

Which FDA product codes apply?

FMI (Needle, hypodermic, single lumen), FMI (Needle, Hypodermic, Single Lumen), OKE (Port introducer kit), LRS (I.V. Start Kit)

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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