FDA.reportPublic FDA data

DOLPHIN

Primary DI
23661234017526
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267476323
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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