AccessGUDID - DEVICE: Nonin (00849686074123)

GUDID

Device Identifier (DI) Information

Brand Name: Nonin
Version or Model: 7600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NONIN MEDICAL, INC.

Primary DI Number: 00849686074123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 174959692 *Terms of Use

Device Description: Regional Oximeter, 2-Channel

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?
17942	Cerebral oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUD	Oximeter, Tissue Saturation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090807	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 Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64db750a-b768-4bea-b5d1-7174d3c632b7
Public Version Date: July 06, 2018
Public Version Number: 3
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
00833166002850	1	00849686074123		In Commercial Distribution	Box

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: 763 553 9968
Email: Regulatory@nonin.com

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