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Device Explorer · FDA GUDID · GMDN 35561

Specimen container mailer, non-insulated

A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is inten

US‑registered devices96in commercial distribution
Companies12labelers on GUDID
Single‑use60%of device records
Sterile2%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Premium Plus International Limited3739%
Caplugs2122%
Globe Scientific Inc.1920%
Fisher Scientific Company L.L.C.55%
Rhinostics Inc33%
Well Lead Medical Co.,Ltd22%
Vericel Corporation22%
Asp Global, Llc22%

Top labelers

CompanyDevicesShare
Premium Plus International Limited3739%
Caplugs2122%
Globe Scientific Inc.1920%
Fisher Scientific Company L.L.C.55%
Rhinostics Inc33%
Well Lead Medical Co.,Ltd22%
Vericel Corporation22%
Asp Global, Llc22%
3D Dental Designs And Development, Llc22%
Postmeds, Inc.11%
Cardinal Health 200, Llc11%
Gynesonics, Inc.11%

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

Brand names on the register (sample)

Specimen Collection BottlePremium PlusRhinostics, Inc.Blood Collection KitVonSeal® 95kPA Biohazard Specimen BagTruepill Inc.LAPCORPGlobe ScientificGlobeScientificEssentials by 3D DentalCaplugs/EvergreenFisherbrandKendallSonata® Intrauterine Ultrasound Probe Return Kit

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

FDA product codes

CodeNameDevices
NNIContainer, Specimen, Non-Sterile49
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE21
NNKContainer, Specimen Mailer And Storage, Non-Sterile15
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE5
FMHContainer, Specimen, Sterile2
FMHCONTAINER, SPECIMEN, STERILE2

GMDN & GCC registration

  • GMDN code 35561 · non‑implantable
  • Single‑use 60% · sterile 2% · Rx‑only 3% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many specimen container mailer, non-insulated products are registered in the US?

96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Specimen container mailer, non-insulated", from 12 companies. The largest labeler is Premium Plus International Limited with 39% of records.

Which FDA product codes apply?

NNI (Container, Specimen, Non-Sterile), KDT (CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE), NNK (Container, Specimen Mailer And Storage, Non-Sterile), NNK (CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE)

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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