FDA UDI In Commercial Distribution 🇺🇸 United States

RLW INTELLIVUE CH.LEAD,5LD,PINCH,39",AHA

DI: 00840828145138 · Model: RLW-05BV-39AS-0000 · CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RLW INTELLIVUE CH.LEAD,5LD,PINCH,39",AHA
Primary DI
00840828145138
Version / Model
RLW-05BV-39AS-0000
Catalog Number
19889
Company Name
CURBELL MEDICAL PRODUCTS, INC.
Labeler DUNS
796452311
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
a56bf1aa-f375-4808-806c-22257c23ae3f

Device Description

RLW INTELLIVUE CH.LEAD,5LD,PINCH,39",AHA

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
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

GMDN Terms

Code Name
35562 Electrocardiographic lead set, reusable

Identifiers

Type ID
Primary 00840828145138

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K081762 000