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Intubation Shield

FDA UDI

Class I (US FDA UDI)

by Paragon Medical, Inc.

Identity

Trade Name
Intubation Shield FDA UDI
Generic Name
Face splash shield, reusable FDA UDI
Device Name
Intubation Shield FDA UDI
Model / Reference
20-P01-00-0000 FDA UDI
Description
Intubation Shield FDA UDI

Identifiers

Catalog Number
20-P01-00-0000 FDA UDI
Primary DI / UDI-DI
00857387006565 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Face splash shield, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Face splash shield, reusable

Intubation Shield by Paragon Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Face splash shield, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon Medical, Inc.

Sources (1)

  • FDA UDI 29536b00-6ef5-4670-bdb9-478be295463f 35 fields · synced Jun 8, 2026