Technical Products

FDA UDI

Class II (US FDA UDI)

by Technical Products, Inc.

Identity

Trade Name: Technical Products FDA UDI
Generic Name: Gas dehumidification tubing set, single-use FDA UDI
Device Name: silicone Tubing FDA UDI
Model / Reference: 601-565 FDA UDI
Description: silicone Tubing FDA UDI

Identifiers

Primary DI / UDI-DI: B0516015650 FDA UDI
510(k) Number: K971613 FDA UDI
FDA Product Code: MIB FDA UDI
GMDN Term: Gas dehumidification tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — .375 Inch FDA UDI

Category: Gas dehumidification tubing set, single-use

A comprehensive gas dehumidification tubing set designed for single-use applications, intended to be used in medical devices. This device is composed of a length of hollow tubing made from one of several malleable or semi-rigid materials and an integrated filter which absorbs humidity before entering the analysing chamber.

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Technical Products — TECHNICAL PRODUCTS, INC. · Class II
Technical Products — TECHNICAL PRODUCTS, INC. · Class II
Technical Products — TECHNICAL PRODUCTS, INC. · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Technical Products, Inc.

Sources (1)

FDA UDI ce1d7381-1a0d-4a5a-bbe3-9862323cc9eb 35 fields · synced Jun 27, 2026