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8001 Series Esophageal/Rectal Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8001-063-409
Identity
- Trade Name
- 8001 Series Esophageal/Rectal Temperature Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Stryker Medical Sterile General Purpose Temperature Probes EUDAMED8001 Series Esophageal/Rectal Temperature Probe FDA UDI
- Model / Reference
- 8001-063-409 EUDAMEDFDA UDI
- Description
- 8001 Series Esophageal/Rectal Temperature Probe FDA UDI
Identifiers
- Catalog Number
- 8001-063-409 FDA UDI
- Primary DI / UDI-DI
- D-H29780010634090DG EUDAMEDH29780010634090 FDA UDI
- Basic UDI-DI
- B-H29780010634090DG EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDI
8001 Series Esophageal/Rectal Temperature Probe by Measurement Specialties, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H29780010634090DG | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Measurement Specialties Inc.
- EUDAMED SRN
- US-MF-000006309
- Authorised Representative
- MEAS Ireland IE-AR-000005162
Sources (2)
- EUDAMED 0d4ebd78-116e-4073-b08d-3bfb791e0aae 61 fields · synced Jul 10, 2026
- FDA UDI 61002083-9d58-46d9-b6d6-de5d3f7bf23c 37 fields · synced May 30, 2026