FDA.reportPublic FDA data

My Medical

Primary DI
G425MM6006250
Brand
My Medical
Company
My Medical Store LLC
Model
600-625
Catalog number
600-625
Device description
Yankauer suction tube 5mm
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G425MM6006250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tubeA hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116446487
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G4250010My MedicalCAL-001CAL-0012026-05-04
G4250020My MedicalCAL-002CAL-0022026-05-04
G425050183SCD0My Medical050-183SCD050-183SCD2026-05-04
G4250601180My Medical060-118060-1182026-05-04
G4250601350My Medical060-135060-1352026-05-04
G4250602970My Medical060-297050-2972026-05-04
G4250602980My Medical060-298060-2982026-05-04
G425110676LSI0My Medical110-676LSI110-676LSI2026-05-04
G425110686LSI0My Medical110-686LSI110-686LSI2026-05-04
G4251902480My Medical190-248190-2482026-05-04
G425310840NC0My Medical310-840NC310-840NC2026-05-04
G4254202900My Medical420-290420-2902026-05-04
G4254203160My Medical420-316420-3162026-05-04
G4254209120My Medical420-912420-9122026-05-04
G4254209140My Medical420-914420-9142026-05-04
G4254402140My Medical440-214440-2142026-05-04
G4254403120My Medical440-312440-3122026-05-04
G425050933SC0My Medical050-933SC050-933SC2026-03-27
G4255721131S0My Medical572-1131S572-1131S2026-02-27
G4250605120My Medical060-512060-5122026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
04054462901975evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901982evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901999evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902002evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902019evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902026evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902033evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902040evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902057evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902064evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902088evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902095evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902118evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902125evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902132evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902149evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904396evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904402evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21