FDA UDI In Commercial Distribution 🇺🇸 United States

DermaFloat

DI: 00810055880386 · Model: DFAPL-3680NCR-M · JOERNS HEALTHCARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DermaFloat
Primary DI
00810055880386
Version / Model
DFAPL-3680NCR-M
Catalog Number
DFAPL-3680NCR-M
Company Name
JOERNS HEALTHCARE, LLC
Labeler DUNS
790937150
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-11
Public Version
1
Public Version Date
2023-08-21
Public Version Status
New
Public Device Record Key
7d6e0a49-7bed-4b84-b792-cb11f13945e3

Device Description

DERMAFLOAT APL MATT 36X80 W/O CAIR RAIL

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
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IKY Mattress, Flotation Therapy, Non-Powered

GMDN Terms

Code Name
47478 Alternating-pressure bed mattress overlay system

Identifiers

Type ID
Primary 00810055880386