FDA.report

EndoVive Y-Port Feeding Adapter

Primary DI
08714729863564
Brand
EndoVive Y-Port Feeding Adapter
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00501260
Device description
Initial Gastrostomy Tube Y-Port Adapter ENFit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PIFGastrointestinal Tubes with Enteral Specific Connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729863564PackageGS110In Commercial Distribution
08714729863557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729863564087147298635648714729863564
08714729863557087147298635578714729863557

GMDN Terms

TermDefinition
ENFit/non-ISO80369-standardized small-bore multichannel connectorA small, non-powered, noninvasive, small-bore, tubular connector with three or more connections, which includes both an ENFit connection(s) [designed according to ISO 80369-3 for enteral applications] and a connection(s) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), designed to connect an enteral device(s) [e.g., enteral syringe, feeding tube, administration set] with an ENFit connection(s) typically to tubing or a syringe. It does not have a Luer or ENLock connection(s), and does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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