FDA UDI In Commercial Distribution 🇺🇸 United States

Battery

DI: 00606959033276 · Model: PAP Li Ion Battery Kit, Sleep, NA · Respironics, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Battery
Primary DI
00606959033276
Version / Model
PAP Li Ion Battery Kit, Sleep, NA
Catalog Number
1124009
Company Name
Respironics, Inc.
Labeler DUNS
080728314
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
5
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
f9db0025-1bf0-4a78-a193-374f004f31ea

Device Description

LI ION Battery Kit, Sleep, North America

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
Yes
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)
CBK VENTILATOR, CONTINUOUS, FACILITY USE
MNS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
MNT VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

GMDN Terms

Code Name
36534 Portable/mobile rechargeable battery pack

Identifiers

Type ID
Primary 00606959033276

Customer Contacts

Storage Conditions

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