N/A - KIT, ACCESSORY AQUILION ONE. Includes: 9006 - - DOMICO MED-DEVICE, LLC

Duns Number:081253414

Device Description: KIT, ACCESSORY AQUILION ONE. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, KIT, ACCESSORY AQUILION ONE. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9077 - PAD, ROLLED EDGE FOOT EXTENSION (00810050241458), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9090 - AQUILION ONE HEAD HOLDER KIT (00810050243216), 9108 - THE SHIELD, AQUILION ONE (00810050242264), 9111 - COVER, PROTECTIVE, AQUILLION ONE PAD (10810050242667), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30" (00810050242158)

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

771d7547-2ece-4d62-b0b0-f8f295f92bb0

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DOMICO MED-DEVICE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 512
2 A medical device with a moderate to high risk that requires special controls. 35