AccessGUDID - DEVICE: Devon (10884521208285)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 580060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 580060
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521208285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Foam Arm Protector with Velcro Straps

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:	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42328	Foam-filled bed mattress overlay	A foam-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, 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. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	SUPPORT, PATIENT POSITION

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
Special Storage Condition, Specify: none;

Clinically Relevant Size

[?]

Size Type Text
Length: 27 Inch
Device Size Text, specify: Length, 1.75, IN;
Height: 20 Inch

Device Record Status

Public Device Record Key: db20af5b-e8b3-498a-8ab5-7b38850ec9f4
Public Version Date: February 15, 2019
Public Version Number: 2
DI Record Publish Date: June 29, 2018