BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

DreamWear

DI: 00606959062139 · Model: DreamWear Silicone Pillows, FitPack Asian Pacific · Respironics, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: DreamWear
Primary DI: 00606959062139
Version / Model: DreamWear Silicone Pillows, FitPack Asian Pacific
Catalog Number: 1146469AP
Company Name: Respironics, Inc.
Labeler DUNS: 080728314
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-12-17
Public Version: 3
Public Version Date: 2025-04-24
Public Version Status: Update
Public Device Record Key: 37331fb5-691d-401b-bf65-84ca4144ba39

Device Description

DreamWear Silicone Pillows, FitPack, Asian Pacific

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: 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: No
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
57815	CPAP/BPAP nasal mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose 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. 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	00606959062139	GS1

Customer Contacts

Phone: +1(724)387-4000
Email: [email protected]

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit