FDA.reportPublic FDA data

DOLPHIN

Primary DI
03661234017522
Brand
DOLPHIN
Company
PEROUSE MEDICAL
Model
0185NA
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAVSyringe, balloon inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042449000DOLPHIN INFLATION DEVICESedat S.A.2005-04-18MAV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661234017526PackageGS16In Commercial Distribution
03661234017522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2366123401752623661234017526
03661234017522036612340175223661234017522

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.

Regulatory Flags#

DUNS number
267476323
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661234027453PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
03661234027460PEROUSE MEDICAL2015SPIMSTVPE2015SPIMST2026-01-22
03661234027477PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
03661234027484PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
13661234027450PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
13661234027467PEROUSE MEDICAL2015SPIMSTVPE2015SPIMST2026-01-22
13661234027474PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
13661234027481PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
03661234017430INFLATION SYSTEM03.804.413S2017-04-12
03661234026883PEROUSE MEDICAL03.804.413SVPE0252NB12025-10-15
03661234025213PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
33661234025214PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
03661234025206PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
33661234025207PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
03661234025190PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
03661234025237PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
43661234025198PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
43661234025235PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
03661234025183PEROUSE MEDICALE63101DLVPEE63101DL2024-03-20
03661234025220PEROUSE MEDICALE63101DRVPEE63101DR2024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
10884450021344DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
10884450021269DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
10884450021252DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002742QL Locking Syringe DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
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
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
06943718223344DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223351DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223368DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223375DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223382DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223337DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223341DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223358DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223365DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223372DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223389DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
20197344104939NAMICMEDLINE INDUSTRIES, INC.MAV2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
20197344013781NAMICMEDLINE INDUSTRIES, INC.MAV2024-06-14