Passio Pump Drainage System

GUDID 00860099001322

Starter Pac

Bearpac Medical, LLC

Thoracic suction pump
Primary Device ID00860099001322
NIH Device Record Key39a0680a-6a67-46de-9947-ece63be8b8b5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePassio Pump Drainage System
Version Model NumberPAS-04
Company DUNS081178202
Company NameBearpac Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com
Phone833-232-7722
Emailcs@bearpac.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860099001322 [Primary]

FDA Product Code

DWMApparatus, Suction, Patient Care

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

Devices Manufactured by Bearpac Medical, LLC

00086000903220 - Passio Redressing Kit2024-03-08
10860099001398 - Passio Valve Cap Kit2024-03-08
00860099001308 - Passio Disposable Collection System2023-09-04
10860099001343 - Passio Catheter Valve Replacement Kit2023-09-04
00860099001322 - Passio Pump Drainage System2023-08-21Starter Pac
00860099001322 - Passio Pump Drainage System2023-08-21 Starter Pac
00860099001353 - Passio Adapter Kit2023-08-21

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