NA

Basic Information

• Brand Name: NA
• Primary DI: 04719873693115
• Version / Model: S2001-A660
• Company Name: CARILEX MEDICAL, INC.
• Labeler DUNS: 658863238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-22
• Public Version: 2
• Public Version Date: 2022-12-16
• Public Version Status: Update
• Public Device Record Key: 20e5e5bc-729c-427a-bd2e-02487240a4d7

Device Description

TheraFlo 7 & 9 Cover 107 x 200cm DTX Carilex-1p

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: No
• Has Lot/Batch Number: Yes
• 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
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	890.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47478	Alternating-pressure bed mattress overlay system	An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04719873693122	GS1		10	Not in Commercial Distribution	2022-12-15
Primary	04719873693115	GS1
Package	14719873693112	GS1		10	In Commercial Distribution