FDA.report

EndoVive Safety PEG Kit

Primary DI
08714729880431
Brand
EndoVive Safety PEG Kit
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00509020
Device description
Percutaneous Endoscopic Gastrostomy Kit 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
08714729880431PackageGS12In Commercial Distribution
08714729880424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729880431087147298804318714729880431
08714729880424087147298804248714729880424

GMDN Terms

TermDefinition
Gastrostomy tube kit, medicatedA collection of devices which includes a gastrostomy tube with a pharmaceutical agent intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube and pharmaceutical agent, the kit might also include additional surgical devices (e.g., scalpel, introduction needle, guidewire, dilator, fastener, lubricant). 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
true
Combination product
true
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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