Identity
- Trade Name
- Pasture A520S Respirator FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. FDA UDI
- Model / Reference
- A520S FDA UDI
- Description
- It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B624A520S200 FDA UDI
- FDA Product Code
- MSH FDA UDI
- GMDN Term
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-use
Pasture A520S Respirator by Pasture Pharma Pte, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical respirator, non-antimicrobial, single-use.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Halyard — O&M HALYARD, INC. · Class II
- Lighthouse Worldwide Solutions Inc — Lighthouse Worldwide Solutions, Inc. · Class II
- Hope — PROGUARD HEALTH INC. · Class II
- Vitacore — Vitacore Industries, Inc. · Class II
- 3M — 3M COMPANY · Class II
- Zhou Medical N95 Respirator Mask — ZHOU MEDICAL SOLUTIONS LLC · Class II
- Moldex — Moldex/Metric, Inc. · Class II
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
- Pasture Pharma Pte, Ltd.
Sources (1)
- FDA UDI 972a31b9-655b-4c6d-9b54-007c76cba584 34 fields · synced May 30, 2026