AccessGUDID - DEVICE: NightBalance (00606959057517)

GUDID

Device Identifier (DI) Information

Brand Name: NightBalance
Version or Model: 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2EU01DK
Company Name: Respironics, Inc.

Primary DI Number: 00606959057517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Philips NightBalance, Denmark

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?
34875	Behavioural therapy electrical stimulation system	An assembly of devices designed to apply harmless but unpleasant electrical impulses to a patient (e.g., in the arm or leg) to modify undesirable behavioural characteristics (e.g., self injurious behaviour). It is typically used for aversion therapy sessions conducted by a therapist and/or in clinical programs at home. Some assemblies include an annoying sound stimulus for sound or sound/electric aversion conditioning. The system is often used in the treatment of obsessive/compulsive behaviour and drug abuse.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYB	Pillow, cervical (for mild sleep apnea)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180608	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 Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16f297cb-1eb8-4ab3-94cd-b8842c5de57a
Public Version Date: October 01, 2020
Public Version Number: 1
DI Record Publish Date: September 23, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30606959057518	30	00606959057517		In Commercial Distribution	Multipack

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(724)387-4000
Email: RESPIRONICS.SERVICE@PHILIPS.COM

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