Arterial Blood Sampling Kit
FDA 510(k)Class II (US FDA 510(k))
by Medex, Inc.
Identifiers
- 510(k) Number
- K902771 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arterial Blood Sampling Kit is a collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label.
This device is supplied as a single-use kit and is classified as a Class 2 device. The kit is used in the cardiovascular medical specialty and is regulated under the product code DQO. The device has been assigned the K number K902771 and has received FDA 510(k) clearance.
Frequently asked questions
What is the Arterial Blood Sampling Kit used for?
The kit is used to obtain an arterial blood specimen directly from a patient, usually for determining blood gas concentration, in the cardiovascular medical specialty.
Is the Arterial Blood Sampling Kit sterile and single-use?
Yes, the kit is supplied as a single-use kit and is sterile, reducing the risk of infection and ensuring patient safety.
What is included in the Arterial Blood Sampling Kit?
The kit typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label.
How is the Arterial Blood Sampling Kit regulated?
The kit is regulated under the product code DQO and has received FDA 510(k) clearance, classified as a Class 2 device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ARTERIAL BLOOD SAMPLING KIT (K902771) — FDA 510(k) | Innolitics, ARTERIAL BLOOD SAMPLING KIT 510 (k) K902771 - FDA.report, AccessGUDID - DEVICE: Medex (10351688516268)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K902771 | Class II | Active |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K902771 24 fields · synced Sep 22, 2026