AccessGUDID - DEVICE: Ingenia (00884838099449)

GUDID

Device Identifier (DI) Information

Brand Name: Ingenia
Version or Model: Acoustic Hood
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989603020982
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838099449
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses. The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations. Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset."

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?
37654	Full-body MRI system, superconducting magnet	A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193215	000
K213583	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 -20 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b8d1ed9-0bd6-48dd-bdca-7d6d6e16bce0
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2022