Identity
- Trade Name
- Reusable Bladderless Cuffs Starter Kit FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Model / Reference
- 115-031807-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904089478 FDA UDI
- 510(k) Number
- K132038 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Blood pressure cuff, reusable
Reusable Bladderless Cuffs Starter Kit by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
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.
- 8Pin SpO2 Extension Cable for Nellcor Se — 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.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI e69842cc-8b42-4d4e-b2ef-4707a386ab52 34 fields · synced May 31, 2026