FDA UDI In Commercial Distribution 🇺🇸 United States

GENDRON

DI: M368RG8001 · Model: RG800 · GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
GENDRON
Primary DI
M368RG8001
Version / Model
RG800
Company Name
GF HEALTH PRODUCTS, INC.
Labeler DUNS
132016168
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-21
Public Version
1
Public Version Date
2025-08-29
Public Version Status
New
Public Device Record Key
29566e39-383a-41ab-ba11-9782848cad59

Device Description

Regency Heavy Duty Bed

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FNL Bed, Ac-Powered Adjustable Hospital

GMDN Terms

Code Name
34870 Basic electric hospital bed

Identifiers

Type ID
Primary M368RG8001

Customer Contacts

Phone
770-368-4700