FDA UDI In Commercial Distribution 🇺🇸 United States

ATMOS Air-Charged Pressure Sensor

DI: 08594211570893 · Model: PS11-21V25 · MEDKONSULT medical technology s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ATMOS Air-Charged Pressure Sensor
Primary DI
08594211570893
Version / Model
PS11-21V25
Company Name
MEDKONSULT medical technology s.r.o.
Labeler DUNS
361814147
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-06
Public Version
1
Public Version Date
2024-11-14
Public Version Status
New
Public Device Record Key
4c13a866-4cfb-47a0-beeb-cc62fc001369

Device Description

Air-Charged Pressure Sensor intended for measurement of urodynamic pressures transmitted by approved types of measuring, air-filled catheters in a set of specified urodynamic measurement systems, vesical 2.5m for MMS

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
FEN Device, Cystometric, Hydraulic

GMDN Terms

Code Name
31278 Air/gas pressure transducer

Identifiers

Type ID
Primary 08594211570893