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Device Explorer · FDA GUDID · GMDN 61445

Endoscope clean-storage system

A mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a

US‑registered devices81in commercial distribution
Companies1labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Plasmabiotics81100%

Top labelers

CompanyDevicesShare
Plasmabiotics81100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NIST medical air probe 7 barNIST medical air probe 4 bar1000 red labels “To disinfect”Autoclavable version of PW90 2C-G-DSilicone connection set for colonoscopes, gastroOzone test strips (12 strips per box)Analogue manometerGas flowrate meterPush-in connectors for PU tubesMetallic push-in connectors for MD-airmed CHPolyurethane tube, int. diam. 5 mm, ext. diam. 8Polyurethane tube, int. diam. 4 mm, ext. diam. 6Autoclavable version of Oly CSilicone connection set for cystoscopes (and ureAutoclavable version of Fg5W 2C-G-DSilicone connection set for colonoscopes, gastro

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

FDA product codes

CodeNameDevices
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 81

GMDN & GCC registration

  • GMDN code 61445 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 0% · OTC 100%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 81Width (Centimeter) · 81Height (Centimeter) · 80Guidewire Length (Centimeter) · 1

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

How many endoscope clean-storage system products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscope clean-storage system", from 1 companies. The largest labeler is Plasmabiotics with 100% of records.

Which FDA product codes apply?

LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted )

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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