Identity
- Trade Name
- XScribe Cardiopulmonary Kit FDA UDI
- Generic Name
- Cardiac stress exercise monitoring system FDA UDI
- Device Name
- Cardiopulmonary accessory kit cleared with XScribe FDA UDI
- Model / Reference
- 41000-030-62 FDA UDI
- Description
- Cardiopulmonary accessory kit cleared with XScribe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817655020068 FDA UDI
- 510(k) Number
- K152944 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Cardiac stress exercise monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac stress exercise monitoring system
XScribe Cardiopulmonary Kit by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152944 also covers:
- AM12Q — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — 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 |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (1)
- FDA UDI 6284ed97-79c8-482c-879a-23dc1e5ded45 36 fields · synced Jun 8, 2026