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ThermalX 361

by Adroit Medical Systems, Inc.

ThermalX 361 (7013-0001) is a patient gown (FDA Class I; FDA product code FME, Gown, Examination) made by Adroit Medical Systems, Inc., listed in FDA GUDID since 4 Oct 2019 (UDI-DI 10615089701303), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10615089701303 UDI-DI Date4 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
ThermalX
Generic name
Patient gown, single-use
Model / Ref / Catalog
361, 7013-0001
Primary DI / UDI-DI
10615089701303
FDA product code
FME
GMDN term
Patient gown, single-use
Device class
Class I
Regulation number
880.6265
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Patient gown, single-use

Similar devices

Other devices filed under FDA product code FME (Gown, Examination).

Other devices from Adroit Medical Systems, Inc.

See all devices from Adroit Medical Systems, Inc. →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)