AccessGUDID - DEVICE: Levmed ECG 12 Lead Electrodes belt (07290016423068)

GUDID

Device Identifier (DI) Information

Brand Name: Levmed ECG 12 Lead Electrodes belt
Version or Model: ARs
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A-11061/s-AL
Company Name: LEVMED LTD

Primary DI Number: 07290016423068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600401224 *Terms of Use

Device Description: Dedicated ECG Electrode Belt with Straps. D-Type With Screws Connector

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":	No
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?
42489	Electrocardiographic electrode, reusable	A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 750e4490-5e57-4b91-8f0b-568c3e8294e2
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 14, 2023

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +011972544361672
Email: info@levmed.net

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