Identity
- Trade Name
- BiTrac Select FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Model / Reference
- 313-9518 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470103385 FDA UDI
- 510(k) Number
- K023683 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP face mask, single-use
BiTrac Select by Pulmodyne Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CPAP/BPAP face mask, single-use.
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Cleared under the same submission
K023683 also covers:
- Medline — MEDLINE INDUSTRIES, INC.
- ADAPT-2-VENT — Pulmodyne Inc.
- BiTrac — Pulmodyne Inc.
- BiTrac — Pulmodyne Inc.
- BiTrac — Pulmodyne Inc.
- BiTrac — Pulmodyne Inc.
- BiTrac — Pulmodyne Inc.
- BiTrac HC — Pulmodyne Inc.
- BiTrac HC — Pulmodyne Inc.
- BiTrac HC — Pulmodyne Inc.
- BiTrac HC — Pulmodyne Inc.
- BiTrac MaxShield — Pulmodyne 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
- Pulmodyne Inc.
Sources (1)
- FDA UDI f24743e6-58f7-41d9-90a8-17947ac6dddb 35 fields · synced May 30, 2026