NA

Basic Information

• Brand Name: NA
• Primary DI: 00471987369297
• Version / Model: S2001-2670
• Company Name: CARILEX MEDICAL, INC.
• Labeler DUNS: 658863238
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-22
• Public Version: 2
• Public Version Date: 2022-08-15
• Public Version Status: Update
• Public Device Record Key: c378d779-bb08-4e93-bf9b-8c0be1611fea
• Distribution End Date: 2022-08-15

Device Description

TheraFlo 9 M-set 90 x 200cm WDTX Carilex

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
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
Primary	00471987369297	GS1