FDA UDI In Commercial Distribution 🇺🇸 United States

Summit Doppler

DI: 00888937002461 · Model: L450VA · Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Summit Doppler
Primary DI
00888937002461
Version / Model
L450VA
Company Name
Coopersurgical, Inc.
Labeler DUNS
801895244
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-21
Public Version
4
Public Version Date
2024-02-28
Public Version Status
Update
Public Device Record Key
738064e3-0b22-47dd-a78e-ddfdf972695f

Device Description

Vista ABI - Automated ABI System: On Screen Guide, PVR, 8 MHz Doppler Probe, Auto Cuff Inflation/Deflation, Stand and 4 Cuffs

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
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
HEK Monitor, Heart Sound, Fetal, Ultrasonic

GMDN Terms

Code Name
58928 Noninvasive ankle brachial pressure index measurement unit

Identifiers

Type ID
Primary 00888937002461