FDA UDI In Commercial Distribution 🇺🇸 United States

MEDACURE

DI: 00869201000222 · Model: CZ36 · MEDACURE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MEDACURE
Primary DI
00869201000222
Version / Model
CZ36
Company Name
MEDACURE INC.
Labeler DUNS
079352467
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-15
Public Version
1
Public Version Date
2019-03-11
Public Version Status
New
Public Device Record Key
f95858a7-ccea-4bc0-8e9f-cbae2bf173c7

Device Description

COMFORT ZONE

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
FNM Mattress, Air Flotation, Alternating Pressure

GMDN Terms

Code Name
17593 Low-air-loss bed

Identifiers

Type ID
Primary 00869201000222