FDA UDI In Commercial Distribution 🇺🇸 United States

Plateau

DI: 00606959020177 · Model: Plateau Exhalation Valve (PEV), Single, Reusable · Respironics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Plateau
Primary DI
00606959020177
Version / Model
Plateau Exhalation Valve (PEV), Single, Reusable
Catalog Number
302312
Company Name
Respironics, Inc.
Labeler DUNS
080728314
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-22
Public Version
6
Public Version Date
2022-11-28
Public Version Status
Update
Public Device Record Key
05e9791e-130c-4c81-9ff4-dba6686dd964

Device Description

Plateau Exhalation Valve (PEV), Single, Reusable

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
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
BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

GMDN Terms

Code Name
42601 Straight/elbow breathing circuit connector, reusable

Identifiers

Type ID
Primary 00606959020177

Customer Contacts

Storage Conditions

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