AccessGUDID - DEVICE: Max-14 Oxygen Sensor (00817770021056)

GUDID

Device Identifier (DI) Information

Brand Name: Max-14 Oxygen Sensor
Version or Model: R116P80-004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MAXTEC, LLC

Primary DI Number: 00817770021056
Issuing Agency: GS1
Commercial Distribution End Date: May 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 169911828 *Terms of Use

Device Description: Ohio Medical 806572

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?
13538	Respiratory oxygen sensor	A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972992	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f80f2f9a-b560-4a06-aa54-0136cf6613ab
Public Version Date: May 07, 2019
Public Version Number: 2
DI Record Publish Date: January 14, 2019

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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