FDA.reportPublic FDA data

EndoVive™ Low Profile Replacement Button

Primary DI
08714729902621
Brand
EndoVive™ Low Profile Replacement Button
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00509840
Catalog number
M00509840
Device description
Low Profile Replacement Gastrostomy Tube
Published
2017-10-30
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

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes with Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729902621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729902621087147299026218714729902621

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153038AMT MiniONE Extension SetAPPLIED MEDICAL TECHNOLOGY, INC.PIF2026-03-23
50192253012505Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253012987Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253068786CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068793CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068816CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068823CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068830CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253011447CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011461CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011515CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011553CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011577CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011614CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
05060999351571EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351601EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351632EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351670EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
20813939024917VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024924VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024931VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024948VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024955VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024962VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
00850016172488KBMEDKB Medical (group), Inc.PIF2025-05-21
00850016172495KBMEDKB Medical (group), Inc.PIF2025-05-21
50192253007570ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007594ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007617ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007631ArgyleCardinal Health 200, LLCPIF2025-04-24