Tom 2 Pediatric Pulse Mattress

Basic Information

• Brand Name: Tom 2 Pediatric Pulse Mattress
• Primary DI: 00845699005864
• Version / Model: 7770-PPM-TOM2
• Company Name: SIZEWISE RENTALS, L.L.C.
• Labeler DUNS: 967025602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-10
• Public Version: 1
• Public Version Date: 2020-11-18
• Public Version Status: New
• Public Device Record Key: 5c7961c2-fde9-4e08-83b9-27255055c6b3

Device Description

Pediatric pulse mattress

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: MR Safe
• 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	Medical Specialty	Regulation #	Device Class
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16168	Flotation therapy bed, neonatal	A fixed (non-adjustable) device designed with a mattress or cushions containing air, water, gel, or other appropriate material used for the continuous care of newborns, and sick and/or premature babies. It has a size to suit such patients and provide environmental conditions (e.g., softness, illumination levels) appropriate for a neonate, as well as good working conditions for the healthcare staff; the bed is frequently mounted on wheels and may include or permit attachments for/to a baby warmer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845699005864	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]