FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 04719873697069 · Model: S2101-A570 · CARILEX MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
NA
Primary DI
04719873697069
Version / Model
S2101-A570
Company Name
CARILEX MEDICAL, INC.
Labeler DUNS
658863238
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-06-20
Public Version
1
Public Version Date
2024-06-28
Public Version Status
New
Public Device Record Key
4e3e01fc-317e-4b2c-8c4b-1e74cac88721

Device Description

Lux/FIT 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
FNM Mattress, Air Flotation, Alternating Pressure

GMDN Terms

Code Name
47478 Alternating-pressure bed mattress overlay system

Identifiers

Type ID
Package 14719873697066
Primary 04719873697069