Identity
- Trade Name
- Schiller SpO2 connecting cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- SpO2 connecting cable LP Nellcor 1.8 m FDA UDI
- Model / Reference
- 2.310244 FDA UDI
- Description
- SpO2 connecting cable LP Nellcor 1.8 m FDA UDI
Identifiers
- Catalog Number
- 2.310244 FDA UDI
- Primary DI / UDI-DI
- 07613365000641 FDA UDI
- 510(k) Number
- K012226 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrical-only medical device connection cable, reusable
Schiller SpO2 connecting cable by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reusable.
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K012226 also covers:
- ARGUS® PB-1000 — Schiller Corp.
- ARGUS® PB-2000 — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
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
- Schiller Corp.
Sources (1)
- FDA UDI b0d79b50-edf5-469b-8fa5-581beba67773 37 fields · synced May 30, 2026