AccessGUDID - DEVICE: Avaline Medical NJ LLC (00850025452625)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: vkpmc100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: vkpmc100
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00850025452625
Issuing Agency: GS1
Commercial Distribution End Date: June 28, 2022
Device Count: 100
Labeler D-U-N-S® Number*: 079767953 *Terms of Use
Previous DI: 00667605029203

Device Description: Plastic Medicine Cups,100

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):	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?
12505	Medicine cup, single-use	A cup specially designed for administering medicine to patients or disabled persons. It is made of disposable plastic and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED

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: c3102ff5-c210-4c90-8c8a-615b42300c37
Public Version Date: June 29, 2022
Public Version Number: 3
DI Record Publish Date: February 18, 2021