AccessGUDID - DEVICE: AMC (00849593018999)

GUDID

Device Identifier (DI) Information

Brand Name: AMC
Version or Model: KT-EDR1222
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advantage Medical Electronics, LLC

Primary DI Number: 00849593018999
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080242300 *Terms of Use

Device Description: LEADWIRE, SNAP to DIN PLUG, 24" BLACK, 10 EA

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60635	Electrocardiographic electrode connector	A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patientÃ¢â‚¬â„¢s skin, with a socket at the other end for a plug on the lead. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992524	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 153ed0fd-6d01-45b9-9f34-393c851bedcd
Public Version Date: February 10, 2023
Public Version Number: 2
DI Record Publish Date: January 26, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 954-345-9800
Email: info@advantagemed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES