Identity
- Trade Name
- Astraguard FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Bacterial Viral Filter FDA UDI
- Model / Reference
- Astraguard FDA UDI
- Description
- Bacterial Viral Filter FDA UDI
Identifiers
- Catalog Number
- F0300-100 FDA UDI
- Primary DI / UDI-DI
- B279F0300100 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
- 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
Category: Breathing mouthpiece, single-use
Astraguard by Sdi Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing mouthpiece, single-use.
- Mouthpiece, Disposable, .900"OD, 2.50" L — A-M Systems, Inc. · Class I
- Mouthpiece, Disposable, 1.125" ID, 2.5" L — A-M Systems, Inc. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
- Disposable Mouthpiece 27mm OD — Vacumed · Class I
- EasySpeak — Intersurgical Incorporated · Class I
- All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
- Mouthpiece, Disposable, 3/4" O.D., 2.625" L — A-M Systems, Inc. · Class I
Cleared under the same submission
K062913 also covers:
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
- Astraguard — SDI DIAGNOSTICS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sdi Diagnostics, Inc.
Sources (1)
- FDA UDI 8cc41e77-0eed-48ff-8d59-39885d627e0c 35 fields · synced May 31, 2026