← Back to catalogue

Sample Container

FDA UDI

Class I (US FDA UDI)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
Sample Container FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Bronchus Sampler is composed of the sampler connector, flow switch, silicone plug and sample container. The Bronchus Sampler is designed as accessory to the Single-use Broncho Videoscope, and intended to enable aspiration and collection of fluid sample from the bronchial or alveolar part of the lung.The sample container is used to connect to the sampler connector, and holds the retrieved sample. FDA UDI
Model / Reference
SC-60 FDA UDI
Description
Bronchus Sampler is composed of the sampler connector, flow switch, silicone plug and sample container. The Bronchus Sampler is designed as accessory to the Single-use Broncho Videoscope, and intended to enable aspiration and collection of fluid sample from the bronchial or alveolar part of the lung.The sample container is used to connect to the sampler connector, and holds the retrieved sample. FDA UDI

Identifiers

Primary DI / UDI-DI
06971381257588 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

Category: General specimen container IVD, no additive/medium

Sample Container by Scivita Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

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
Scivita Medical Technology Co., Ltd.

Sources (1)

  • FDA UDI 485d94b2-b757-4e49-8a53-0f957e9660c8 34 fields · synced Jun 8, 2026