ASEPT 622284

GUDID 04046964317330

ASEPT PERITONEAL DRAINAGE SYSTEM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peritoneal drainage catheter
Primary Device ID04046964317330
NIH Device Record Key030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameASEPT
Version Model Number622284
Catalog Number622284
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964317330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJSCATHETER, PERITONEAL, LONG-TERM INDWELLING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2015-07-26

On-Brand Devices [ASEPT]

04046964317514ASEPT PLEURAL DRAINAGE SYSTEM
04046964317330ASEPT PERITONEAL DRAINAGE SYSTEM

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