Identity
- Trade Name
- Silvercrest FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate). FDA UDI
- Model / Reference
- IAN 387871_2101 FDA UDI
- Description
- SPO55 Pulse Oximeter intended for wellness use in measuring the blood oxygen saturation and the heart rate (pulse rate). FDA UDI
Identifiers
- Catalog Number
- 454.12 FDA UDI
- Primary DI / UDI-DI
- 04055334330404 FDA UDI
- FDA Product Code
- PGJ FDA UDI
- GMDN Term
- Pulse oximeter 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
Silvercrest by Lidl Us, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
- Nonin — Nonin Medical, Inc. · Class II
- acurio — XIAMEN ACURIO INSTRUMENT CO., LTD · Class II
- MightySat — MASIMO CORPORATION · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Andesfit — ANDESFIT LIMITED · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
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
- Lidl Us, Llc
Sources (1)
- FDA UDI 5ea16284-465b-4747-af87-bf4c5a98659c 34 fields · synced May 30, 2026