AccessGUDID - DEVICE: MYO/Wire® Ultra-Thin Temporary Pacing Wires (08718627411957)

GUDID

Device Identifier (DI) Information

Brand Name: MYO/Wire® Ultra-Thin Temporary Pacing Wires
Version or Model: VF608ACBBG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: A & E MEDICAL CORPORATION

Primary DI Number: 08718627411957
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 173770868 *Terms of Use

Device Description: MYO/Wire® Ultra-Thin Bipolar V - 60cm - Blue - Flare 8mm electrode

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
Prescription Use (Rx):	No
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?
45966	Transthoracic pacing lead	A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. The other end initially is typically attached to a removable needle used to perforate the chest wall from the inside out, after which it is connected to a pulse generator, typically via an adaptor. This device is only used for temporary pacing of the heart and is removed once the patient is stable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDF	ELECTRODE, PACEMAKER, TEMPORARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033858	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: ff184758-b3f0-4bb0-bde8-0a1d95b8b8d3
Public Version Date: February 04, 2019
Public Version Number: 5
DI Record Publish Date: November 11, 2015