AccessGUDID - DEVICE: Spacelabs Healthcare (10841522121753)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: 90200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 015-0721-01
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522121753
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: MICRO-V ALTERNANS SENSOR(MV4),POUCH OF 7,UDI

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":	Yes
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?
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
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050225	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
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bb0cecd0-5018-46ea-a797-f8f112c73de0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 08, 2017