Agiliti Health

GUDID 00845699046386

65-05-0000 & 65-05-0010 Essentia™

SIZEWISE RENTALS, L.L.C.

Bariatric bed

• Primary Device ID: 00845699046386
• NIH Device Record Key: 600429cb-3940-435d-98e7-02f528c1769b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agiliti Health
• Version Model Number: Medical Bed (FNL)
• Company DUNS: 967025602
• Company Name: SIZEWISE RENTALS, L.L.C.
• 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: true
• 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
GS1	00845699046386 [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: 2024-09-30
• Device Publish Date: 2024-09-20

Devices Manufactured by SIZEWISE RENTALS, L.L.C.

• 00845699002412 - Sizewise: 2024-09-30 Big Turn - 39" x 86"
• 00845699002429 - Sizewise: 2024-09-30 Big Turn - 48" x 86"
• 00845699002436 - Sizewise: 2024-09-30 Mighty Air - 39" x 86"
• 00845699002443 - Sizewise: 2024-09-30 Mighty Air - 48" x 86"
• 00845699002450 - Sizewise: 2024-09-30 Bariatric Pulsate - 39" x 86"
• 00845699002474 - Sizewise: 2024-09-30 NP12 "G" Series - 39" x 80"
• 00845699002481 - Sizewise: 2024-09-30 NP12 "G" Series - 42" x 80"
• 00845699002498 - Sizewise: 2024-09-30 NP12 "G" Series Expandable - 39"/48" x 80"