FDA UDI In Commercial Distribution 🇺🇸 United States

DreamStation Go

DI: 00606959055896 · Model: DreamStation Go Humidifier, WE · Respironics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DreamStation Go
Primary DI
00606959055896
Version / Model
DreamStation Go Humidifier, WE
Catalog Number
WEGH
Company Name
Respironics, Inc.
Labeler DUNS
080728314
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-05
Public Version
3
Public Version Date
2023-02-06
Public Version Status
Update
Public Device Record Key
8dda0317-1a21-49c2-8bbb-d1814d3d3b23

Device Description

DreamStation Go Heated Humidifier, Western Europe

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
MR Unsafe
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
BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

GMDN Terms

Code Name
12050 Heated respiratory humidifier

Identifiers

Type ID
Primary 00606959055896

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