FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 04719873697106 · Model: S2101-A610 · CARILEX MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
NA
Primary DI
04719873697106
Version / Model
S2101-A610
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
98e1a260-1cf8-422b-9652-99832ba014fe

Device Description

Lux/FIT cover 42" x 80" WDTX 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 14719873697103
Primary 04719873697106