Identity
- Trade Name
- Makrite Industries Inc. FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size. FDA UDI
- Model / Reference
- 9500-N95 FDA UDI
- Description
- NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973875280027 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-use
Makrite Industries Inc. by Makrite Hubei Industrial Co., 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.
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- 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
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
- Makrite Hubei Industrial Co., Ltd.
Sources (1)
- FDA UDI 55c0c056-a730-459b-847a-ed0305a7a099 33 fields · synced May 29, 2026