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Passio Disposable Collection System

FDA UDI

Class II (US FDA UDI)

by Bearpac Medical, Llc

Identity

Trade Name
Passio Disposable Collection System FDA UDI
Generic Name
Pleural/peritoneal drainage catheterization kit FDA UDI
Model / Reference
PAS-07 FDA UDI

Identifiers

Primary DI / UDI-DI
00860099001308 FDA UDI
510(k) Number
K201404 FDA UDI
FDA Product Code
DWM FDA UDI
GMDN Term
Pleural/peritoneal drainage catheterization kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pleural/peritoneal drainage catheterization kit

Passio Disposable Collection System by Bearpac Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural/peritoneal drainage catheterization kit.

Cleared under the same submission

K201404 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bearpac Medical, Llc

Sources (1)

  • FDA UDI 9d8c7893-5d23-4357-9d36-4cef2b7f528d 35 fields · synced May 30, 2026