Identity
- Trade Name
- Tri-Seal mouthseal 50/bx FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- blue vinyl, 22mm OD, 50/bx FDA UDI
- Model / Reference
- 1007 FDA UDI
- Description
- blue vinyl, 22mm OD, 50/bx FDA UDI
Identifiers
- Catalog Number
- 1007 FDA UDI
- Primary DI / UDI-DI
- 00850644007695 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing mouthpiece, single-use
Tri-Seal mouthseal 50/bx by Vacumed — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing mouthpiece, single-use.
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- PFT — Vitalograph Ireland, Ltd. · Class II
- EasySpeak — Intersurgical Incorporated · Class I
- All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
- Mouthpiece, Disposable, 3/4" O.D., 2.625" L — A-M Systems, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Vacumed
Sources (1)
- FDA UDI 7729d346-d028-42fe-a6b2-ada724b4ba10 35 fields · synced Jun 8, 2026