FDA UDI Not in Commercial Distribution 🇺🇸 United States

PHILIPS HeartStart FR3 with Text and Soft Case

DI: 00884838051416 · Model: 861499 · PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PHILIPS HeartStart FR3 with Text and Soft Case
Primary DI
00884838051416
Version / Model
861499
Catalog Number
861499
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
5
Public Version Date
2023-09-14
Public Version Status
Update
Public Device Record Key
fd75469f-e4e2-433f-b2a9-7baaec91ef6d
Distribution End Date
2021-01-06

Device Description

FR3 Text, US English, Soft System Bundle

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
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
MKJ Automated External Defibrillators (Non-Wearable)

GMDN Terms

Code Name
48047 Non-rechargeable public automated external defibrillator

Identifiers

Type ID
Primary 00884838051416