AccessGUDID - DEVICE: Sleep Profiler (00850015266706)

GUDID

Device Identifier (DI) Information

Brand Name: Sleep Profiler
Version or Model: SP42-5402
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED BRAIN MONITORING, INC.

Primary DI Number: 00850015266706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969842715 *Terms of Use

Device Description: Sleep Profiler RTA Software

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?
47567	Polysomnography analyser	A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120450	000
K130007	000
K153412	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: 32a381b7-88fc-46f2-be70-abbd42afe216
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023

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

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES