AccessGUDID - DEVICE: OptoMonitor (07540184020102)

GUDID

Device Identifier (DI) Information

Brand Name: OptoMonitor
Version or Model: Optical Unit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F2010
Company Name: Opsens Inc

Primary DI Number: 07540184020102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 253717946 *Terms of Use

Device Description: No description.

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?
10980	Cardiac catheterization laboratory computer	A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip
DQX	Wire, Guide, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142598	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
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 010b6b04-598f-4a6a-b56f-1d08c2e656c5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 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: 418-781-0333
Email: info-medical@opsens.com

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