Identity
- Trade Name
- Astraguard FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Bacterial viral filter FDA UDI
- Model / Reference
- Pneumoguard Adapter FDA UDI
- Description
- Bacterial viral filter FDA UDI
Identifiers
- Catalog Number
- 29-7994-100 FDA UDI
- Primary DI / UDI-DI
- B279S297994100 FDA UDI
- 510(k) Number
- K062913 FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- 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
Yes
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. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sdi Diagnostics, Inc.
Sources (1)
- FDA UDI a4344340-ce11-4feb-98ad-d0156225ffe5 36 fields · synced May 31, 2026