PVC Thoracic Catheters

FDA UDI

Class I (US FDA UDI)

by Atrium Medical Corp.

Identity

Trade Name: PVC Thoracic Catheters FDA UDI
Generic Name: Pleural catheter FDA UDI
Device Name: 12 FR Straight – Soft PVC Catheter FDA UDI
Model / Reference: 8012 FDA UDI
Description: 12 FR Straight – Soft PVC Catheter FDA UDI

Identifiers

Catalog Number: 8012 FDA UDI
Primary DI / UDI-DI: 20650862130120 FDA UDI
FDA Product Code: GBZ FDA UDI
GMDN Term: Pleural catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 12 French FDA UDI

Category: Pleural catheter

PVC Thoracic Catheters by Atrium Medical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pleural catheter.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Atrium Medical Corp.

Sources (1)

FDA UDI 70cd8362-f142-4573-9ef1-3cb354ff3e84 35 fields · synced May 30, 2026