FDA.reportPublic FDA data

Encore 26

Primary DI
08714729755241
Brand
Encore 26
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00566670
Device description
Inflation Device
Published
2016-09-24
Public version status
Update
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
MAVSyringe, balloon inflation
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729755241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729755241087147297552418714729755241

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00884450544648basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
00884450638514basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
10197344203475NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
00884450440612basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
10889942546350NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
00884450098684basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450220092basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450098288basixTOUCH™Merit Medical Systems, Inc.PTM2025-10-07
00724995244538LumiflexUS EndoscopyPTM2025-08-19
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00884450860373BIG60™Merit Medical Systems, Inc.PTM2025-05-31
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
20859500005169StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
00884450860953basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
00884450621370basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450621394basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
10884450822514basixSKY™Merit Medical Systems, Inc.PTM2024-12-28
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
10197344104932NAMICMEDLINE INDUSTRIES, INC.PTM2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06