AccessGUDID - DEVICE: Assembly Required Distributors (00854362008842)

GUDID

Device Identifier (DI) Information

Brand Name: Assembly Required Distributors
Version or Model: IVM1920-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Assembly Required Distributors Inc

Primary DI Number: 00854362008842
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 170562396 *Terms of Use

Device Description: Arm Pad Cushion, black urethane

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	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?
61153	Infusion/transfusion trolley	A cart designed to accommodate the equipment necessary for infusion/transfusion of intravenous products. The trolley will typically have stands, hangers, drawers, and/or shelves to hold equipment and tubing during the treatment process. It may be equipped with additional elements such as trays, needle, and/or catheter containers and clinical waste bins. It is intended to be used in clinical environments where transfusion/infusion procedures occur [e.g., a blood transfusion centre, intensive care unit (ICU), and accident and emergency (A&E) unit].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion

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: 7a782237-97b8-47f6-9ec3-48e07233ec2d
Public Version Date: October 04, 2023
Public Version Number: 2
DI Record Publish Date: September 19, 2019