BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

N/A

DI: 00817136027289 · Model: 7700 · HANS RUDOLPH, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Basic Information

Brand Name: N/A
Primary DI: 00817136027289
Version / Model: 7700
Catalog Number: 612780
Company Name: HANS RUDOLPH, INC.
Labeler DUNS: 007131725
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2023-04-05
Public Version: 2
Public Version Date: 2023-06-30
Public Version Status: Update
Public Device Record Key: 2a81e8e5-0d7f-4e33-9adf-edb572cd1d14
Distribution End Date: 2023-06-30

Device Description

SWIVEL PORT V2 QREL 22ID PCYEL

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
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: Yes
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57814	CPAP/BPAP face mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817136027289	GS1

Premarket Submissions

Submission Number	Supplement Number
K030822	000