AccessGUDID - DEVICE: Moor Instruments Ltd (15060484490027)

GUDID

Device Identifier (DI) Information

Brand Name: Moor Instruments Ltd
Version or Model: moorVMS-OXY
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOOR INSTRUMENTS LIMITED

Primary DI Number: 15060484490027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 398037580 *Terms of Use

Device Description: moorMVS-OXY - Tissue Oxygen and Temperature Monitor

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:	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?
46615	Tissue saturation oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUD	Oximeter, Tissue Saturation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112826	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
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fe4b872-ae48-4d82-8366-eb229a485921
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016

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: +44129735715
Email: service@moor.co.uk

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