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Astraguard

FDA UDI

Class II (US FDA UDI)

by Sdi Diagnostics, Inc.

Identity

Trade Name
Astraguard FDA UDI
Generic Name
Breathing mouthpiece, single-use FDA UDI
Device Name
Bacterial filter FDA UDI
Model / Reference
Flotube FDA UDI
Description
Bacterial filter FDA UDI

Identifiers

Catalog Number
F0303-100 FDA UDI
Primary DI / UDI-DI
B279F0303100 FDA UDI
510(k) Number
K062913 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Breathing mouthpiece, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Astraguard by Sdi Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K062913 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sdi Diagnostics, Inc.

Sources (1)

  • FDA UDI e9a845cc-ecb1-4a76-b42a-870ec64ae35f 36 fields · synced May 31, 2026