FDA UDI In Commercial Distribution 🇺🇸 United States

HeartStart

DI: 20884838015245 · Model: External Paddles Water Resistant · Philips Medical Systems Hsg
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HeartStart
Primary DI
20884838015245
Version / Model
External Paddles Water Resistant
Catalog Number
M3543A
Company Name
Philips Medical Systems Hsg
Labeler DUNS
790605856
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-24
Public Version
6
Public Version Date
2023-07-31
Public Version Status
Update
Public Device Record Key
0839769c-43f8-4cca-857e-be24961d2cd2

Device Description

External Paddles - Water Resistant

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
MKJ Automated External Defibrillators (Non-Wearable)

GMDN Terms

Code Name
41062 External defibrillation electrode, adult, reusable

Identifiers

Type ID
Primary 20884838015245