BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

NAMIC

DI: H965700583170 · Model: 70058317 · NAVILYST MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: NAMIC
Primary DI: H965700583170
Version / Model: 70058317
Company Name: NAVILYST MEDICAL, INC.
Labeler DUNS: 809699023
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-20
Public Version: 4
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: bcc080bd-3e8a-4f4c-8575-9aadb3399635

Device Description

Perceptor Compensator Manifold Medium Pressure

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRS	TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR	Cardiovascular	870.2850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35927	Invasive-pressure external transducer, single-use	A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H965700583171	HIBCC	BOX	10	In Commercial Distribution
Primary	H965700583170	HIBCC

Customer Contacts

Phone: +1(518)795-1676
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K951722	000