FDA.reportPublic FDA data

Hydra

Primary DI
00840253111920
Brand
Hydra
Company
BOSTON SCIENTIFIC CORPORATION
Model
SCT-611
Catalog number
SCT-611
Device description
Water Bottle Cap System
Published
2020-11-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
FEQPUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840253108531PackageGS110Not in Commercial Distribution
00840253111920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840253108531008402531085318402531085310840253108531
00840253111920008402531119208402531119200840253111920

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, reusableA collection of flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.

Regulatory Flags#

DUNS number
021717889
Device count
1
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
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M710TCW101200Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2024-01-31
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.FEQ2024-01-22
00724995228903DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228910DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228927DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228934DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228941DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228958DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228965DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228908DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228946DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995227340NAUS EndoscopyFEQ2023-11-13
04065655000436ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000689ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000887ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000917ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000948ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655000979ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001006ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655001037ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001068ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001099ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000375ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22