FDA UDI In Commercial Distribution 🇺🇸 United States

Hospital Wearable Defibrillator

DI: 00855778005272 · Model: HWD 1000 Therapy Electrode · ZOLL MANUFACTURING CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Hospital Wearable Defibrillator
Primary DI
00855778005272
Version / Model
HWD 1000 Therapy Electrode
Catalog Number
10A1009
Company Name
ZOLL MANUFACTURING CORPORATION
Labeler DUNS
079320559
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-13
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
35143e45-01f4-405f-a46f-59bc257e9794

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MVK Wearable Automated External Defibrillator

GMDN Terms

Code Name
48051 Wearable defibrillation system

Identifiers

Type ID
Package 10855778005279
Primary 00855778005272