FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 04713616096362 · Model: S2001-A780 · CARILEX MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
NA
Primary DI
04713616096362
Version / Model
S2001-A780
Company Name
CARILEX MEDICAL, INC.
Labeler DUNS
658863238
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-03-01
Public Version
3
Public Version Date
2024-04-25
Public Version Status
Update
Public Device Record Key
a43122b3-ffc5-45fb-9ee8-6af9b03d1cbb

Device Description

TheraFlo 7 & 9 Cover 36" x 80" VTX 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
IOQ Bed, Flotation Therapy, Powered

GMDN Terms

Code Name
47478 Alternating-pressure bed mattress overlay system

Identifiers

Type ID
Package 04713616096379
Primary 04713616096362
Package 14713616096369