FDA UDI
In Commercial Distribution
🇺🇸 United States
Tilcare Oral Dispenser with Cover
DI: 05060665920124
·
Model: ORAL DISPENSER WITH COVER 5ML
·
TILCO TRADING PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tilcare Oral Dispenser with Cover
- Primary DI
- 05060665920124
- Version / Model
- ORAL DISPENSER WITH COVER 5ML
- Company Name
- TILCO TRADING PTE. LTD.
- Labeler DUNS
- 659506330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-18
- Public Version
- 2
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- e966a773-acd8-458d-8d86-ad8b33e928fb
Device Description
Oral Dispenser with Cover 5ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 35754 | Oral liquid dose dispenser cabinet | An electrically-powered device designed to distribute oral liquid medication/vitamins in a healthcare facility in the amount needed for a single dose for an individual patient. It typically consists of a small cabinet with an electronic pump that contains unit-dose packaged liquid drugs (e.g., glass ampules, sealed plastic containers) and/or containers with multiple doses that dispense an exact amount of liquid at a time. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060665920128 | GS1 | 600 | In Commercial Distribution | ||
| Primary | 05060665920124 | GS1 | ||||
| Package | 15060665920121 | GS1 | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +6531388052
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |