Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Paper chart recorder FDA UDI
- Device Name
- Thermal Printer 50 mm Roll With Housing FDA UDI
- Model / Reference
- 901011 FDA UDI
- Description
- Thermal Printer 50 mm Roll With Housing FDA UDI
Identifiers
- Catalog Number
- 5450-007-50 FDA UDI
- Primary DI / UDI-DI
- 00732094258639 FDA UDI
- 510(k) Number
- K123556 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Paper chart recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Paper chart recorder
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123556 also covers:
- AM12M — MORTARA INSTRUMENT, INC.
- AM12M — MORTARA INSTRUMENT, INC.
- AM12M — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, INC.
- Surveyor S12 — MORTARA INSTRUMENT, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI c30fd2d6-df34-49e8-bf45-0bf9280c52a7 36 fields · synced Jun 8, 2026