Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- OXIMETER,PULSE,FINGER,SOFT-TOUCH,W/CASE FDA UDI
- Model / Reference
- HCSM70G FDA UDI
- Description
- OXIMETER,PULSE,FINGER,SOFT-TOUCH,W/CASE FDA UDI
Identifiers
- Catalog Number
- HCSM70G FDA UDI
- Primary DI / UDI-DI
- 10197344037513 FDA UDI
- 510(k) Number
- K140582 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
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- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
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- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
Cleared under the same submission
K140582 also covers:
- 1BYONE — 1BYONEPRODUCTS INC.
- Pulse Oximeter — BETTER BASICS, INC.
- Pulse oximeter — BETTER BASICS, INC.
- Pulse oximeter — BETTER BASICS, INC.
- Areta Fingertip Pulse Oximeter — EASY HEALTHCARE CORPORATION
- EMAY — EMAY (HK) LIMITED
- Touch — LEXINGTON WELLNESS HOLDINGS INC.
- FaceLake — LORTE TECHNOLOGIES, INC
- iProvèn — Masena Invest B.V.
- BV Medical — Medical, Inc.
- Alcedo — Nature Major Inc.
- Pylo Health — PREVOUNCE HEALTH, INC
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 658c712c-a2cb-48e8-90df-36c3677ad121 37 fields · synced May 30, 2026