FDA.reportPublic FDA data

VETA Peritoneal Dialysis Catheter

Primary DI
00813623019249
Brand
VETA Peritoneal Dialysis Catheter
Company
PFM MEDICAL INCORPORATED
Model
M7230
Catalog number
M7230
Device description
VETA Peritoneal Dialysis Introducer Kit
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPJPeritoneal Dialysis Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPJPeritoneal Dialysis Administration KitGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113354000VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.2012-03-13FJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813623019246PackageGS15In Commercial Distribution
20813623019243PackageGS120In Commercial Distribution
00813623019249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081362301924610813623019246
2081362301924320813623019243
00813623019249008136230192498136230192490813623019249

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter, acute/chronicA tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane, and capable of being utilized for acute and chronic peritoneal dialysis. It may be surgically or endoscopically implanted, percutaneously, for long-term use; or percutaneously inserted for one-session dialysis. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7607588749regulatory@pfmmedicalusa.com

Regulatory Flags#

DUNS number
097736867
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813623011144ASEPT Peritoneal Drainage System6222796222792016-10-01
00813623015371ASEPT Peritoneal Drainage SystemM7000M70002015-10-15
00813623017016ASEPT Pleural Drainage SystemM7001M70012016-10-02
00813623012066ASEPTM7050M70502016-10-05
00813623017054ASEPTM7005M70052019-03-31
00813623040878Jet-VacM7098M70982019-03-31
00813623040885Jet-VacM7097M70972019-03-31
00813623011267BBraun Multi-Snare6129706129702016-09-29
00813623011274BBraun Multi-Snare6129716129712016-09-29
00813623011281BBraun Multi-Snare6129726129722016-09-29
00813623011298BBraun Multi-Snare6129736129732016-09-29
00813623011304BBraun Multi-Snare6129746129742016-09-29
00813623011311BBraun Multi-Snare6129756129752016-09-29
00813623011328BBraun Multi-Snare6129766129762016-09-29
00813623010352Tita Jet616.368.3077-HAV616.368.3077-HAV2021-05-31
00813623010369Tita Jet616.368.2087-HAV616.368.2087-HAV2021-05-31
00813623010376Jet Port616.367.3077-HAV616.367.3077-HAV2021-05-31
00813623010383Jet Port616.367.2087-HAV616.367.2087-HAV2021-05-31
00813623010390Jet Port616.021.0078-HAV616.021.0078-HAV2021-05-31
00813623010406Tita Jet616.022.0078-HAV616.022.0078-HAV2021-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20813623019243VETA Peritoneal Dialysis CatheterPFM MEDICAL INCORPORATEDPPJ2015-10-15