FDA.reportPublic FDA data

ASEPT

Primary DI
00813623012066
Brand
ASEPT
Company
PFM MEDICAL INCORPORATED
Model
M7050
Catalog number
M7050
Device description
ASEPT 1000mL Drainage Bottle with Y-Site Drain
Published
2016-10-05
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
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813623012063PackageGS110In Commercial Distribution
00813623012066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081362301206310813623012063
00813623012066008136230120668136230120660813623012066

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kitA collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607588749regulatory@pfmmedicalusa.com

Regulatory Flags#

DUNS number
097736867
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains 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
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
00813623010413Tita Jet616.360.9070-HAV616.360.9070-HAV2021-05-31

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Primary DI, Brand, Company table
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14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
00628725095363Pleural Drain Dry Seal System CHS USA Inc.KDQ2026-04-17
00628725095370Pleural Drain Wet Seal System CHS USA Inc.KDQ2026-04-17
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
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