Identity
- Trade Name
- SourceMark FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Model / Reference
- M0555U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813799001147 FDA UDI
- 510(k) Number
- K042683 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Basic endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic endotracheal tube, single-use
SourceMark by Sourcemark, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic endotracheal tube, single-use.
- AVANOS — Avanos Medical, Inc. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
- Mallinckrodt — Covidien LP · Class II
- RediTube™ — Airlife, Inc. · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- Endotracheal Tubes — Dynarex Corp. · Class II
- ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
Cleared under the same submission
K042683 also covers:
- AMSure® Endotracheal Tube — AMSINO INTERNATIONAL, INC.
- RediTube™ — Airlife, Inc.
- Vital Signs™ — Airlife, Inc.
- Endotracheal Tubes — Dynarex Corp.
- Endotracheal Tubes — Dynarex Corp.
- Endotracheal Tubes — Dynarex Corp.
- Endotracheal Tubes — Dynarex Corp.
- Endotracheal Tubes — Dynarex Corp.
- Resp-O2 Endotracheal Tube, Uncuffed, 2.5 mm — Dynarex Corp.
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
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
- Sourcemark, Llc.
Sources (1)
- FDA UDI 52d8ad0e-98e1-4a29-8ce9-69e0d1b31204 33 fields · synced Jun 1, 2026