FDA UDI
In Commercial Distribution
🇺🇸 United States
Chemtrue
DI: 00850019007282
·
Model: 711C02CT
·
CHEMTRON BIOTECH INC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chemtrue
- Primary DI
- 00850019007282
- Version / Model
- 711C02CT
- Catalog Number
- 711C02CT
- Company Name
- CHEMTRON BIOTECH INC
- Labeler DUNS
- 795658603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3c4d9827-26cb-440f-adbf-3d830e7ea866
Device Description
Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43954 | Y-piece breathing circuit connector, reusable | A connecting device shaped in the form of a "Y" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is made of durable materials, e.g., plastic and/or metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019007282 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142396 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius