FDA UDI Not in Commercial Distribution 🇺🇸 United States

PHILIPS HeartStart OnSite

DI: 00884838050693 · Model: 861337 · PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PHILIPS HeartStart OnSite
Primary DI
00884838050693
Version / Model
861337
Catalog Number
861337
Company Name
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Labeler DUNS
079503890
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-24
Public Version
6
Public Version Date
2023-04-28
Public Version Status
Update
Public Device Record Key
97b60979-8740-45c9-b06e-3d7cfa0cbed1
Distribution End Date
2016-06-10

Device Description

Guidelines Update, Home

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
NSA Over-The-Counter Automated External Defibrillator

GMDN Terms

Code Name
48050 Home automated external defibrillator

Identifiers

Type ID
Primary 00884838050693