FDA UDI In Commercial Distribution 🇺🇸 United States

Eclipse Pro

DI: 10841522129681 · Model: Eclipse Pro · SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Eclipse Pro
Primary DI
10841522129681
Version / Model
Eclipse Pro
Catalog Number
700-0391-00
Company Name
SPACELABS HEALTHCARE (WASHINGTON), INC
Labeler DUNS
145581588
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-23
Public Version
1
Public Version Date
2023-08-31
Public Version Status
New
Public Device Record Key
6b6a0be3-582b-43a1-ae0a-a79b87521fa0

Device Description

ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,MEDIUM

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MWJ Electrocardiograph, ambulatory (without analysis)

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 10841522129681