FDA UDI In Commercial Distribution 🇺🇸 United States

AMC

DI: 00849593011402 · Model: CB-713600 · Advantage Medical Electronics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AMC
Primary DI
00849593011402
Version / Model
CB-713600
Company Name
Advantage Medical Electronics, LLC
Labeler DUNS
080242300
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-23
Public Version
4
Public Version Date
2023-02-10
Public Version Status
Update
Public Device Record Key
5a9e7356-ac74-4e91-9488-f1b8a0fa95fe

Device Description

3 Lead New NK 12 Pin CN to Din, Patient Cable

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
Yes
MRI Safety
MR Unsafe
Direct Marking Exempt
Yes
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
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 00849593011402

Customer Contacts

Phone
954-345-9800

Premarket Submissions

Submission Number Supplement Number
K992524 000