Device
The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement
Manufacturer
Fysicon B.V.
Fysicon B.V.
Model: Disposable NiBP Cuff, Neonate (Burgundy), 8-15 cm, Box 20 pcs
Catalog: 01853009
DI: 08719689142544
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement
system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP
cuffs are a single bladder and shell construction, use to support ease of cleaning.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f46385c2-e388-4f01-b59c-d67ab831dfea
Distribution Status:
In Commercial Distribution
DUNS Number:
404866654
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08719689142544
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67106
Name: Multiple physiological parameter monitoring support kit
Definition:
A collection of noninvasive devices intended to be used in conjunction with a parent physiological parameter monitor for enabling measurement of multiple vital parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), temperature]. It typically includes an inflatable blood pressure cuff, patient temperature probe, and electrical cables for connection to the monitor (e.g., for connecting an ECG lead to the monitor). This is a reusable device.
FDA Product Codes
DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
Premarket Submissions
Submission Number:
K241766
Supplement Number:
000