AccessGUDID - DEVICE: NIMBUS (05055982782234)

GUDID

Device Identifier (DI) Information

Brand Name: NIMBUS
Version or Model: 650001DAR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arjohuntleigh AB

Primary DI Number: 05055982782234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355804758 *Terms of Use

Device Description: Mattress Cover - Alternating Pressure - Nimbus (Reliant IS) Length 2085mm (82"), Width 890mm (35") Height 215mm (8.5")

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):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Alternating-pressure bed mattress overlay system	An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

GMDN Preferred Term Name

GMDN Definition

Alternating-pressure bed mattress overlay system

An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

FDA Product Code

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Product Code	Product Code Name
FNM	MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f631f9c7-80c6-42b2-8bdc-35a854247ba0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016