Identity
- Trade Name
- Chemtrue FDA UDI
- Generic Name
- Y-piece breathing circuit connector, reusable FDA UDI
- Device Name
- Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit FDA UDI
- Model / Reference
- 711C02CT FDA UDI
- Description
- Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit FDA UDI
Identifiers
- Catalog Number
- 711C02CT FDA UDI
- Primary DI / UDI-DI
- 00850019007282 FDA UDI
- 510(k) Number
- K142396 FDA UDI
- FDA Product Code
- LDJ FDA UDILAF FDA UDIDIO FDA UDI
- GMDN Term
- Y-piece breathing circuit connector, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3610 FDA UDI862.3250 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Y-piece breathing circuit connector, reusable
Chemtrue by Chemtron Biotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Y-piece breathing circuit connector, reusable.
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Cleared under the same submission
K142396 also covers:
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, 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 |
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Manufacturer
- Manufacturer
- Chemtron Biotech, Inc.
Sources (1)
- FDA UDI 3c4d9827-26cb-440f-adbf-3d830e7ea866 36 fields · synced May 30, 2026