FDA.reportPublic FDA data

ThermalX

Primary DI
10615089702003
Brand
ThermalX
Company
ADROIT MEDICAL SYSTEMS, INC.
Model
901
Catalog number
7020-0001
Device description
Rescue Wrap, Full closure Bag
Published
2019-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20615089702000PackageGS110Not in Commercial Distribution
10615089702003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061508970200020615089702000
1061508970200310615089702003

GMDN Terms#

Term, Definition table
TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
8654588600kelley@adroitmedical.com

Regulatory Flags#

DUNS number
795104769
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10615089100304Soft-TempST-003ST-0032016-09-23
10615089100809Soft-TempST-008ST-0082016-09-23
10615089101004Soft-TempST-010ST-0102016-09-23
10615089101400Soft-TempST-014ST-0142016-09-23
10615089101707Soft-TempST-017ST-0172016-09-23
10615089101905Soft-TempST-019ST-0192016-09-23
10615089102407Soft-TempST-024ST-0242016-09-23
10615089103008Soft-TempST-030ST-0302016-09-23
10615089104104Soft-TempST-041ST-0412016-09-23
10615089104302Soft-TempST-043ST-0432016-09-23
10615089104401Soft-TempST-044ST-0442016-09-23
10615089105002Soft-TempST-050ST-0502016-09-23
10615089111706Soft-TempWD-017WD-0172016-09-23
10615089112000Soft-TempWD-020WD-0202016-09-23
10615089113007Soft-TempWD-030WD-0302016-09-23
10615089116008Soft-TempWD-060WD-0602016-09-23
10615089121200Soft-TempST-212ST-2122016-09-23
10615089121705Soft-TempST-217ST-2172016-09-23
10615089122009Soft-TempST-220ST-2202016-09-23
10615089122405Soft-TempST-224ST-2242016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942015441PRIMEDpriMED Medical Products IncFME2026-02-10
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
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00842942017537PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942007828PRIMEDpriMED Medical Products IncFME2025-07-21
00842942008207PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009341PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009358PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009372PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
00842942013928PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014475PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014482PRIMEDpriMED Medical Products IncFME2025-07-21
00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15