Identity
- Trade Name
- VS Cap Extra Small FDA UDI
- Generic Name
- Neonatal multi-parameter bedside monitor FDA UDI
- Device Name
- VS Cap Extra Small FDA UDI
- Model / Reference
- SP-159-A-1 FDA UDI
- Description
- VS Cap Extra Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060550650006 FDA UDI
- 510(k) Number
- K201887 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Neonatal multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Neonatal multi-parameter bedside monitor
VS Cap Extra Small by Surepulse Medical Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal multi-parameter bedside monitor.
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Surepulse Medical Limited
Sources (2)
- FDA UDI 929cbcee-cf74-428e-9db0-6fe265b26f04 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026