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Benesta Fluid Pack

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name
Benesta Fluid Pack FDA UDI
Generic Name
Surgical suction system Y-piece valve-connector FDA UDI
Device Name
Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals. FDA UDI
Model / Reference
CAL-1411 FDA UDI
Description
Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals. FDA UDI

Identifiers

Primary DI / UDI-DI
00857492008119 FDA UDI
FDA Product Code
HIH FDA UDI
GMDN Term
Surgical suction system Y-piece valve-connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 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

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: Surgical suction system Y-piece valve-connector

Benesta Fluid Pack by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical suction system Y-piece valve-connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA UDI b19b09e0-674e-4987-a063-172ea51f5991 35 fields · synced May 30, 2026