Aquarius

Basic Information

• Brand Name: Aquarius
• Primary DI: 07290001603994
• Version / Model: 102148101280AQ
• Company Name: DEGANIA SILICONE LTD
• Labeler DUNS: 600007082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 070c508c-688e-42a5-9fce-6ba5be3a081f

Device Description

STOMA MEASURING DEVICE 12FR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63942	Gastrostomy depth sizer	A device intended to be used to measure the depth of a gastrointestinal stoma, from its opening to its terminus within the body, to help in the selection of an appropriately sized gastrostomy appliance (gastrostomy tube). It is typically in the form of a graduated catheter, intended to be inserted into the stoma, which may include an inflatable balloon at the distal end to secure its position after insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290001603998	GS1		2	In Commercial Distribution
Primary	07290001603994	GS1
Package	47290001603992	GS1		50	In Commercial Distribution