FDA UDI In Commercial Distribution 🇺🇸 United States

Hygenic

DI: 00087453001662 · Model: 15583 · HYGENIC CORPORATION, THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Hygenic
Primary DI
00087453001662
Version / Model
15583
Company Name
HYGENIC CORPORATION, THE
Labeler DUNS
004163390
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-13
Public Version
1
Public Version Date
2026-01-21
Public Version Status
New
Public Device Record Key
1368fa46-03e8-48f3-aa10-678426bde915

Device Description

Moist Electric Heating Pad – Large 13x13

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IRT Pad, Heating, Powered

GMDN Terms

Code Name
62194 Electric pad localized-body heating system

Identifiers

Type ID
Primary 00087453001662