FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471189027
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
P30-121
Catalog number
P30-121
Device description
ECO PULSE TIP - SHOWER SPRAY WITH SUCTION
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15051471189024PackageGS15In Commercial Distribution
05051471189027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147118902415051471189024
05051471189027050514711890275051471189027

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac ablation system irrigation tubing setA collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458064144
Device count
1
DM exempt
false
Premarket exempt
true
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
05051471220195De Soutter Medical21630216302026-03-24
05051471220812De Soutter MedicalS83-8069S83-80692026-03-02
05051471220836De Soutter MedicalS83-8169S83-81692026-03-02
05051471220263De Soutter MedicalS89-1482S89-14822026-01-29
05051471219625De Soutter MedicalS83-9499S83-94992026-01-05
05051471215283De Soutter Medical21530215302025-12-04
05051471219038De Soutter MedicalS83-9399S83-93992025-12-04
05051471219175De Soutter MedicalS56-9655S56-96552025-12-04
05051471219199De Soutter MedicalS89-9655S89-96552025-12-04
05051471214453De Soutter Medical21440214402025-09-17
05051471214460De Soutter Medical21450214502025-09-17
05051471214477De Soutter Medical21460214602025-09-17
05051471214484De Soutter Medical21470214702025-09-17
05051471214491De Soutter Medical21480214802025-09-17
05051471214507De Soutter Medical21490214902025-09-17
15051471214788De Soutter MedicalT20-110T20-1102025-09-12
15051471214795De Soutter MedicalT20-173T20-1732025-09-12
15051471217123De Soutter MedicalT20-171T20-1712025-09-12
15051471217130De Soutter MedicalT20-172T20-1722025-09-12
05051471217140De Soutter Medical21520215202025-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50382909101206SurgiphorCAREFUSION 2200, INCFQH2026-03-05
10075450844334Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
10850073677039Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677063Skin-ClensAsept Pak, Inc.FQH2026-02-17
06970462546825Irrigation PumpShenzhen HugeMed Medical Technical Development Co., Ltd.FQH2026-02-10
15051471214788De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471214795De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217123De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217130De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
00810025928858Caring Mill Saline Wound WashCaring MillFQH2025-07-03
20850073677005Shur-ClensAsept Pak, Inc.FQH2025-04-30
00860006476038Shur-ClensAsept Pak, Inc.FQH2025-04-23
00842351120040Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
ESUM930081200SutterSutter Medizintechnik GmbHFQH2024-06-24
00817278012020Patriot ProMed Michigan Holdings, LLCFQH2024-06-04
05051471211735De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
05051471211742De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720958PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720965PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721085CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721108CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11