Identity
- Trade Name
- Pasture F550G Respirator FDA UDI
- Generic Name
- Public respirator, single-use FDA UDI
- Device Name
- This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies. FDA UDI
- Model / Reference
- F550G FDA UDI
- Description
- This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B624F550G200 FDA UDI
- 510(k) Number
- K083176 FDA UDI
- FDA Product Code
- NZJ FDA UDI
- GMDN Term
- Public respirator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6260 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Public respirator, single-use
Pasture F550G Respirator by Pasture Pharma Pte, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Public respirator, single-use.
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Cleared under the same submission
K083176 also covers:
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
- Pasture Pharma Pte, Ltd.
Sources (1)
- FDA UDI d25ed0dc-1bfb-4499-b1c8-78e6865135b9 35 fields · synced May 30, 2026