Tom 2

Basic Information

• Brand Name: Tom 2
• Primary DI: 08592654210970
• Version / Model: 1K5B554-9
• Company Name: L I N E T spol. s r.o.
• Labeler DUNS: 644544504
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-07
• Public Version: 1
• Public Version Date: 2019-11-15
• Public Version Status: New
• Public Device Record Key: 9da3b1d6-a449-43b7-9495-1ccc06dba6a0

Device Description

Pediatric hospital 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: Yes
• 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
FMS	Bed, Pediatric Open Hospital	General Hospital	880.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37010	Paediatric bed	A bed with appropriate size for children (typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and moveable and latchable siderails. It allows children complete freedom in bed without the danger of falling out, yet allows staff access to the patient. Paediatric beds are not appropriate for neonates/infants.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08592654210970	GS1