FDA UDI
In Commercial Distribution
🇺🇸 United States
Doselogix
DI: 00813360022366
·
Model: TC9-P-ORANGE
·
TEAM TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Doselogix
- Primary DI
- 00813360022366
- Version / Model
- TC9-P-ORANGE
- Catalog Number
- 755202
- Company Name
- TEAM TECHNOLOGIES, INC.
- Labeler DUNS
- 078550672
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 1
- Public Version Date
- 2022-09-22
- Public Version Status
- New
- Public Device Record Key
- 7f5dcc1c-3caf-4ff9-9304-1a83f6406b64
Device Description
DOSELOGIX TC9-P-ORANGE WITH POINTED APPLICATOR 8 CAVITY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12505 | Medicine cup, single-use | A cup specially designed for administering medicine to patients or disabled persons. It is made of disposable plastic and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813360022363 | GS1 | Bag | 25 | In Commercial Distribution | |
| Primary | 00813360022366 | GS1 | ||||
| Package | 20813360022360 | GS1 | Case | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 160 Degrees Fahrenheit