← Back to catalogue

SAM Medical

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name
SAM Medical FDA UDI
Generic Name
Pleural catheter FDA UDI
Device Name
Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage. FDA UDI
Model / Reference
RT200-G1-EN FDA UDI
Description
Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage. FDA UDI

Identifiers

Catalog Number
RT200-G1-EN FDA UDI
Primary DI / UDI-DI
00860412001572 FDA UDI
FDA Product Code
JOL FDA UDI
GMDN Term
Pleural catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Pleural catheter

SAM Medical by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ZIEN Medical Technologies, LLC

Sources (1)

  • FDA UDI 48d60125-ad7e-464a-be71-69713fed4462 34 fields · synced May 29, 2026