FDA.reportPublic FDA data

Aquarius

Primary DI
07290001603994
Brand
Aquarius
Company
DEGANIA SILICONE LTD
Model
102148101280AQ
Device description
STOMA MEASURING DEVICE 12FR
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290001603998PackageGS12In Commercial Distribution
47290001603992PackageGS150In Commercial Distribution
07290001603994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729000160399827290001603998
4729000160399247290001603992
07290001603994072900016039947290001603994

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy depth sizerA 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.

Regulatory Flags#

DUNS number
600007082
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884522000017Covidien AG90051T2025-04-03
30884522000028Covidien AG90052T2025-04-03
30884522000035Covidien AG90053T2025-04-03
30884522000042Covidien AG90054T2025-04-03
30884522000059Covidien AG90055T2025-04-03
30884522000066Covidien AG90056T2025-04-03
20884522000014Covidien AG90051T2025-04-03
10884522000024Covidien AG90052T2025-04-03
10884522000031Covidien AG90053T2025-04-03
10884522000048Covidien AG90054T2025-04-03
10884522000055Covidien AG90055T2025-04-03
10884522000062Covidien AG90056T2025-04-03
07290110066512Covidien AG102201101680TY2025-03-04
27290110066516Covidien AG102201101680TY2025-03-04
07290110066475Covidien AG102201100880TY2025-02-20
07290110066482Covidien AG102201101080TY2025-02-20
07290110066499Covidien AG102201101280TY2025-02-20
07290110066505Covidien AG102201101480TY2025-02-20
07290110066529Covidien AG102201101880TY2025-02-20
27290110066479Covidien AG102201100880TY2025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146344MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146375MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146382MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146795MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146801MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147136MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147143MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147150MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147167MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147174MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147181MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147211MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147228MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147273MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147280MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146634MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146641MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146672MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146689MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19