FDA.reportPublic FDA data

ASEPT

Primary DI
00813623017047
Brand
ASEPT
Company
PFM MEDICAL INCORPORATED
Model
M7004
Catalog number
M7004
Device description
ASEPT Replacement Valve
Published
2019-03-31
Public version status
New
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
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093796000ASEPT PERITONEAL DRAINAGE SYSTEMPfm Medical, Inc.2010-02-26PNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813623017044PackageGS15In Commercial Distribution
20813623017041PackageGS120In Commercial Distribution
00813623017047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081362301704410813623017044
2081362301704120813623017041
00813623017047008136230170478136230170470813623017047

GMDN Terms#

Term, Definition table
TermDefinition
Pleural drainage valveA sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
760-758-8749customerservice@pfmmedicalusa.com

Regulatory Flags#

DUNS number
097736867
Device count
1
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

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Primary DI, Brand, Company table
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10884450620523Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620547Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620601Aspira®Merit Medical Systems, Inc.PNG2025-10-02
10884450620608Aspira®Merit Medical Systems, Inc.PNG2025-10-02
00860009032200Passio Redressing KitBearpac Medical, LLCPNG2025-08-08
00884450620557Aspira®Merit Medical Systems, Inc.PNG2025-06-03
10884450620554Aspira®Merit Medical Systems, Inc.PNG2025-06-03
00884450544969Aspira®Merit Medical Systems, Inc.PNG2025-04-21
10884450544966Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00884450751305Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00801741230608PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230615PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230639PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230605PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230612PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230636PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00884450544952Aspira®Merit Medical Systems, Inc.PNG2024-03-06
10884450544959Aspira®Merit Medical Systems, Inc.PNG2024-03-06
00086000903220Passio Redressing KitBearpac Medical, LLCPNG2024-02-29
00860099001322Passio Pump Drainage SystemBearpac Medical, LLCPNG2023-08-11
00884450534311Aspira®Merit Medical Systems, Inc.PNG2022-12-07
10884450534318Aspira®Merit Medical Systems, Inc.PNG2022-12-07
00884450534304Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10884450534301Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10885403500831PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403500848PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502040PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502378N/ACAREFUSION 2200, INCPNG2021-03-09