FDA UDI In Commercial Distribution 🇺🇸 United States

Comfort

DI: 05999569240024 · Model: Comfort-1 Eco · DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Comfort
Primary DI
05999569240024
Version / Model
Comfort-1 Eco
Catalog Number
723C1E01
Company Name
DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Labeler DUNS
401512397
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-04-22
Public Version
1
Public Version Date
2025-04-30
Public Version Status
New
Public Device Record Key
28543e8b-e797-4780-a4a8-d66062f751d1

Device Description

An electrically powered thearapy chair used to position the patient in a sitting, semi-sitting, or reclined posture for easy access and patient comfort during an examination, treatment, or surgical intervention.

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GBB Chair, Surgical, Ac-Powered

GMDN Terms

Code Name
38447 General examination/treatment chair, electric

Identifiers

Type ID
Primary 05999569240024

Customer Contacts

Phone
+3637311990

Device Sizes

Type Value Unit Text
Weight 70 Kilogram

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
– 80 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-10 – 50 Degrees Celsius