Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Curaplex Finger Tip Pulse Oximeter FDA UDI
- Model / Reference
- 69100MS FDA UDI
- Description
- Curaplex Finger Tip Pulse Oximeter FDA UDI
Identifiers
- Catalog Number
- 69100MS FDA UDI
- Primary DI / UDI-DI
- 00812277030945 FDA UDI
- 510(k) Number
- K082641 FDA UDI
- FDA Product Code
- DQA 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
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
Category: Pulse oximeter
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082641 also covers:
- Care One — Ahold U.S.A., Inc.
- Amazon Basic Care — Amazon.com Services, LLC
- Good Neighbor — Amerisourcebergen Drug Corporation
- Good Neighbor — Amerisourcebergen Drug Corporation
- Pulse oximeter — BETTER BASICS, INC.
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- microdot® — Cambridge Sensors USA, LLC.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Virginia National Guard — Clinical Guard
- CONTEC — Contec Medical Systems Co., Ltd.
- CONTEC — Contec Medical Systems Co., Ltd.
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
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 2f20af98-6dd4-4240-8ae6-2c1e975f11e7 36 fields · synced May 30, 2026