FDA UDI In Commercial Distribution 🇺🇸 United States

Finapres

DI: 08719327007129 · Model: Height Correction Unit NC · Finapres Medical Systems B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Finapres
Primary DI
08719327007129
Version / Model
Height Correction Unit NC
Catalog Number
FP_903903
Company Name
Finapres Medical Systems B.V.
Labeler DUNS
489470686
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-11-30
Public Version
1
Public Version Date
2018-12-31
Public Version Status
New
Public Device Record Key
cab8b6fb-4d01-4839-815d-db517219ca44

Device Description

Height Correction Unit NC

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
No
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
DXN System, Measurement, Blood-Pressure, Non-Invasive
DSB Plethysmograph, Impedance

GMDN Terms

Code Name
36551 Patient monitoring system module, blood pressure, noninvasive

Identifiers

Type ID
Primary 08719327007129

Premarket Submissions

Submission Number Supplement Number
K173916 000