AccessGUDID - DEVICE: Aquoral (00196852643219)

GUDID

Device Identifier (DI) Information

Brand Name: Aquoral
Version or Model: 196852643219
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: K Pharmaceuticals, LLC

Primary DI Number: 00196852643219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 047318115 *Terms of Use

Device Description: Saliva substitue - protective oral spray

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:	No
Prescription Use (Rx):	Yes
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?
16529	Medication spray bottle	An empty, flexible squeeze-container with a spray nozzle used to deliver medication in an atomized form, e.g., nasal spray. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEP	MEDIA, MOUNTING, OIL SOLUBLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051812	000

Device Exempt from Premarket Submission: No 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: 9984b18d-cfe3-4298-b53e-ab3c3ed4152b
Public Version Date: August 04, 2023
Public Version Number: 1
DI Record Publish Date: July 27, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10196852643216 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(630)319-0778
Email: info@kpharmaceutical.com

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