AccessGUDID - DEVICE: Assure® Slide Pill Swallowing Aid zero (00015482100032)

GUDID

Device Identifier (DI) Information

Brand Name: Assure® Slide Pill Swallowing Aid zero
Version or Model: 1000003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482100032
Issuing Agency: GS1
Commercial Distribution End Date: September 19, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)

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?
60365	Pill swallowing lubricant	A substance intended to be directly administered in the oral cavity, or combined with a tablet/capsule prior to oral administration, to facilitate pill deglutition (swallowing). It is available in spray or gel form and formulated to function as a lubricant (e.g., contains glycerol). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXB	Dispenser, Solid Medication

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
Storage Environment Temperature: between 35 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f71c4505-6ea6-495c-8b26-4af4f2100ab6
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: December 28, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20015482100036	24	10015482100039	2023-09-19	Not in Commercial Distribution	Master Shipper
10015482100039	4	00015482100032	2023-09-19	Not in Commercial Distribution	Case Pack