Identity
- Trade Name
- 8Pin SpO2 Extension Cable for Nellcor Se FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 0010-20-42712 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904003818 FDA UDI
- 510(k) Number
- K132038 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrical-only medical device connection cable, reusable
8Pin SpO2 Extension Cable for Nellcor Se by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Electrical-only medical device connection cable, reusable.
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- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K132038 also covers:
- 6Pin SpO2 Extension Cable — Shenzhen Mindray Bio-Medical Electronics Co.
- 7Pin Mindray SpO2 cable, 1.2m — Shenzhen Mindray Bio-Medical Electronics Co.
- 7Pin SpO2 Extension Cable — Shenzhen Mindray Bio-Medical Electronics Co.
- Bedrail clamp (VS) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Adult Cuff(CM1303 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Adult long Cuff(CM1306 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Child Cuff(CM1301 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless L-Adult long Cuff(CM1307 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Large Adult Cuff(CM1304 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Small Adult Cuff(CM1302 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Bladderless Thigh Cuff(CM1305 MW) — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable Bladderless Adult Cuff — Shenzhen Mindray Bio-Medical Electronics Co.
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 |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI b0c74aa1-48a1-4bde-a0e8-3c630741e9ce 34 fields · synced May 29, 2026