FDA.report

Marina Medical

Primary DI
00840306806414
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
254-648
Catalog number
254-648
Device description
Multifunction Yankauer ( Suction, Light and Irrigation ) , Universal Adapter ,
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FFYAdaptor, bulbs, miscellaneous, for endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306806414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306806414008403068064148403068064140840306806414

GMDN Terms

TermDefinition
Pin-indexed adaptor, reusableA connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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