FDA.reportPublic FDA data

Passio Disposable Collection System

Primary DI
00860099001308
Brand
Passio Disposable Collection System
Company
Bearpac Medical, LLC
Model
PAS-07
Published
2023-08-25
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
DWMApparatus, Suction, Patient Care

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWMApparatus, Suction, Patient CareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201404000Passio Pump Drainage SystemBearpac Medical2020-11-20DWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860099001305PackageGS110In Commercial Distribution
00860099001308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086009900130510860099001305
00860099001308008600990013088600990013080860099001308

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-232-7722cs@bearpac.com

Regulatory Flags#

DUNS number
081178202
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860099001322Passio Pump Drainage SystemPAS-042023-08-11
00860099001346Passio Catheter Valve Replacement KitPAS-052023-08-25
00860099001391Passio Valve Cap KitPAS-132024-02-29
00860009032200Passio Redressing KitPAS-022025-08-08
00086000903220Passio Redressing KitPAS-022024-02-29
00860099001353Passio Adapter KitPAS-062023-08-11
00860099001315Passio Handheld Control UnitPAS-032025-07-07
10860099001398Passio Valve Cap KitPAS-132024-02-29
10860099001343Passio Catheter Valve Replacement KitPAS-052023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450772515Aspira®Merit Medical Systems, Inc.DWM2026-03-27
00884450620588Aspira®Merit Medical Systems, Inc.DWM2026-03-05
10884450620585Aspira®Merit Medical Systems, Inc.DWM2026-03-05
00884450620564Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620595Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620561Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620592Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620649Aspira®Merit Medical Systems, Inc.DWM2025-10-21
10884450620646Aspira®Merit Medical Systems, Inc.DWM2025-10-21
00860009032200Passio Redressing KitBearpac Medical, LLCDWM2025-08-08
00860099001315Passio Handheld Control UnitBearpac Medical, LLCDWM2025-07-07
00884450620625Aspira®Merit Medical Systems, Inc.DWM2025-05-29
10884450620622Aspira®Merit Medical Systems, Inc.DWM2025-05-29
00884450620632Aspira®Merit Medical Systems, Inc.DWM2025-01-23
10884450620639Aspira®Merit Medical Systems, Inc.DWM2025-01-23
00860099001391Passio Valve Cap KitBearpac Medical, LLCDWM2024-02-29
00086000903220Passio Redressing KitBearpac Medical, LLCDWM2024-02-29
10860099001398Passio Valve Cap KitBearpac Medical, LLCDWM2024-02-29
00884450544990Aspira®Merit Medical Systems, Inc.DWM2024-01-30
10884450544997Aspira®Merit Medical Systems, Inc.DWM2024-01-30
05055270982643RocketROCKET MEDICAL PLCDWM2023-10-23
05055270982650RocketROCKET MEDICAL PLCDWM2023-10-23
05055270982339RocketROCKET MEDICAL PLCDWM2023-10-20
05055270982346RocketROCKET MEDICAL PLCDWM2023-10-20
00860099001346Passio Catheter Valve Replacement KitBearpac Medical, LLCDWM2023-08-25
10860099001343Passio Catheter Valve Replacement KitBearpac Medical, LLCDWM2023-08-25
00860099001322Passio Pump Drainage SystemBearpac Medical, LLCDWM2023-08-11
00860099001353Passio Adapter KitBearpac Medical, LLCDWM2023-08-11
10885403502378N/ACAREFUSION 2200, INCDWM2021-03-09
10885403502385N/ACAREFUSION 2200, INCDWM2021-03-09