AccessGUDID - DEVICE: AcanthusTM (00860010482605)

GUDID

Device Identifier (DI) Information

Brand Name: AcanthusTM
Version or Model: NCH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NCH
Company Name: Acanthus Medical Creations LLC

Primary DI Number: 00860010482605
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2023
Device Count: 60
Labeler D-U-N-S® Number*: 065124205 *Terms of Use

Device Description: Acanthus Nasal Cannula Holder (30 pairs)

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
31072	Personal device holder, single-use	A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAY	Support, Breathing Tube

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: fa5905c9-27ed-4d3d-abaf-cf52f95c34ee
Public Version Date: August 04, 2023
Public Version Number: 2
DI Record Publish Date: June 05, 2023