Identity
- Trade Name
- KIT,SAMPLE,AGENTS,3160 FDA UDI
- Generic Name
- Exhaled-gas sample collector, non-electronic FDA UDI
- Device Name
- KIT,SAMPLE,AGENTS,3160 FDA UDI
- Model / Reference
- Kit, Sample, Agents, 3160 FDA UDI
- Description
- KIT,SAMPLE,AGENTS,3160 FDA UDI
Identifiers
- Catalog Number
- 94018 FDA UDI
- Primary DI / UDI-DI
- 00884838107304 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Exhaled-gas sample collector, non-electronic 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
Yes
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
No
FDA UDI
Category: Exhaled-gas sample collector, non-electronic
Kit, Sample, Agents, 3160 by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exhaled-gas sample collector, non-electronic.
- RTube — RESPIRATORY RESEARCH, INC. · Class I
- GAS COLLECTING VESSEL — Hangzhou A-Tek Medical & Textiles Co., Ltd. · Class I
- KIT, SAMPLE, AGENTS, 3160 — Philips DS North America LLC · Class II
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
- Philips DS North America LLC
Sources (1)
- FDA UDI b4ad0392-0d06-4191-a9fc-3cfb965dc874 35 fields · synced Jun 8, 2026