Identity
- Trade Name
- Amazon Basic Care FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Amazon Basic Care Pulse Oximeter FDA UDI
- Model / Reference
- B09S3W7SW7 FDA UDI
- Description
- Amazon Basic Care Pulse Oximeter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195515047944 FDA UDI
- 510(k) Number
- K082641 FDA UDI
- FDA Product Code
- OCH FDA UDI
- GMDN Term
- Pulse oximeter probe, 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
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
No
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 probe, reusable
Amazon Basic Care by Amazon.com Services, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, reusable.
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- APK — Apk Technology · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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Cleared under the same submission
K082641 also covers:
- Care One — Ahold U.S.A., Inc.
- Good Neighbor — Amerisourcebergen Drug Corporation
- Good Neighbor — Amerisourcebergen Drug Corporation
- Pulse oximeter — BETTER BASICS, INC.
- Curaplex — BOUND TREE MEDICAL, LLC
- 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
- Amazon.com Services, LLC
Sources (1)
- FDA UDI 859b10b4-e236-4801-8105-81277a6e36d4 34 fields · synced May 31, 2026