Identity
- Trade Name
- Busse Hospital Disposables FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Procedural Masks FDA UDI
- Model / Reference
- 371 FDA UDI
- Description
- Procedural Masks FDA UDI
Identifiers
- Catalog Number
- 371 FDA UDI
- Primary DI / UDI-DI
- 00849233000933 FDA UDI
- 510(k) Number
- K940720 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, single-use
Busse Hospital Disposables by Robert Busse & Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, single-use.
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- Precept® — Precept Medical Products, Inc. · Class II
- Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · Class II
Cleared under the same submission
K940720 also covers:
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
- Busse Hospital Disposables — ROBERT BUSSE & CO., 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 |
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Manufacturer
- Manufacturer
- Robert Busse & Co., Inc.
Sources (1)
- FDA UDI cb47440b-6e1c-444a-8b32-e2855b4046fa 36 fields · synced May 31, 2026