GENDRON

GUDID M368RG800A1

Regency Heavy Duty Bed APS

GF HEALTH PRODUCTS, INC.

Basic electric hospital bed

• Primary Device ID: M368RG800A1
• NIH Device Record Key: 36b51fa5-9b24-4211-929b-064d96bef4de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENDRON
• Version Model Number: RG800A
• Company DUNS: 132016168
• Company Name: GF HEALTH PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M368RG800A1 [Primary]

FDA Product Code

• FNL: Bed, Ac-Powered Adjustable Hospital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-29
• Device Publish Date: 2025-08-21

On-Brand Devices [GENDRON]

• M368GS4842SD1: Bed, Bariatric S/Frame
• M368GS4748SB1: Bed, Bariatric S/Frame
• M368GS4054D1: Bed, Bariatric
• M368GS4748SD1: Bed, Bariatric S/Frame
• M368GS36481: Bed, Homecare
• M368G30207501: BARIATRC WHEELCHAIR CUSHION 30X20X4
• M368G28207501: BARIATRC WHEELCHAIR CUSHION 28X20X4
• M368G26207501: BARIATRC WHEELCHAIR CUSHION 26X20X4
• M368G26187501: BARIATRC WHEELCHAIR CUSHION 26X18X4
• M368G24207501: BARIATRC WHEELCHAIR CUSHION 24X20X4
• M368G24187501: BARIATRC WHEELCHAIR CUSHION 24X18X4
• M368GS4842D1: MAXIREST SPLIT FRAME 39-48" X 80"
• M368GT4XL1: SLING,BARIATRIC (400-800 LBS)
• M368TRC28750FB1: TILT RECL BARI CHR 28''SEAT WD
• M368TRC287501: TILT RECL BARI CHR 28''SEAT WD
• M368PL800S1: PATIENT LIFT 800LB CAP, SCALE
• M368PL8001: PATIENT LIFT 800LB CAPACITY
• M368PL700S1: PATIENT LIFT 700LB CAP, SCALE
• M368PL7001: PATIENT LIFT 700LB CAPACITY
• M368PL1000S1: PATIENT LIFT 1000LB CAP, SCALE
• M368PL10001: PATIENT LIFT 1,000LB CAPACITY
• M368GT5XLC1: SLING, BAR COMMODE 400-1000LBS
• M368GT5XL1: SLING,BARIATRIC (400-1000 LBS)
• M3687155P1861: RECL BARI WINE 25.25" SEAT WD
• M3687155P1831: RECL BARI BLK 25.25" SEAT WD
• M3687155P1801: RECL BARI BRWN 25.25" SEAT WD
• M3687155P11991: RECL BARI BLUE 25.25" SEAT WD
• M3687155P11171: RECL BARI GREY 25.25" SEAT WD
• M3687150P1861: RECL BARI WINE 29.25" SEAT WD
• M3687150P1831: RECL BARI BLK 29.25" SEAT WD
• M3687150P1801: RECL BARI BRWN 29.25" SEAT WD
• M3687150P11991: RECL BARI BLUE 29.25" SEAT WD
• M3687150P11171: RECL BARI GREY 29.25" SEAT WD
• M368RG800A1: Regency Heavy Duty Bed APS
• M368RG8001: Regency Heavy Duty Bed