Identity
- Trade Name
- mySentry™ FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- REPEATER MMT-9102NAR MYSNTRY SIG EN RPL FDA UDI
- Model / Reference
- MMT-9102NAR FDA UDI
- Description
- REPEATER MMT-9102NAR MYSNTRY SIG EN RPL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994545527 FDA UDI
- PMA Number
- P980022 FDA UDI
- FDA Product Code
- MDS FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose multi-parameter bedside monitor
mySentry™ by Medtronic Minimed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LiDCO — LIDCO LIMITED · Class II
Cleared under the same submission
P980022 also covers:
- CGMS® iPro™ — MEDTRONIC MINIMED, INC.
- GUARDIAN® — MEDTRONIC MINIMED, INC.
- MiniLink® — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, 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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Minimed, Inc.
Sources (1)
- FDA UDI 1f3e2f36-a58b-4d0f-b47e-3f6ddf76f3d9 36 fields · synced May 30, 2026