AccessGUDID - DEVICE: Ambu WhiteSensor 0315M BIOTABSECG Electrodes (05060038514448)

GUDID

Device Identifier (DI) Information

Brand Name: Ambu WhiteSensor 0315M BIOTABSECG Electrodes
Version or Model: 0315M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0315M
Company Name: Ambu A/S

Primary DI Number: 05060038514448
Issuing Agency: GS1
Commercial Distribution End Date: May 15, 2022
Device Count: 100
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu White Sensor 0315M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
35035	Electrocardiographic electrode, single-use	A non-sterile, 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, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use 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
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0dd72782-2d20-4872-acb0-3b3fcd407b01
Public Version Date: May 16, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2016