AccessGUDID - DEVICE: Oxygen Sensor (04036616000505)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Sensor
Version or Model: OOM202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-00-0047
Company Name: EnviteC-Wismar GmbH

Primary DI Number: 04036616000505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330943838 *Terms of Use

Device Description: Oxygen Sensor OOM202

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
Premarket Submission Number Not Available/Not Released

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 Atmospheric Pressure: between 60 and 200 KiloPascal
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 99 Degrees Celsius
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 30 Millimeter
Width: 150 Millimeter
Length: 247 Millimeter

Device Record Status

Public Device Record Key: 0f515474-14a1-4d39-a53f-736b7a63dc38
Public Version Date: April 27, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 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: Yes
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: +493841360324
Email: christian.walsleben@honeywell.com

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