FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Assure® Slide Pill Swallowing Aid forte
DI: 00015482100025
·
Model: 1000002
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Assure® Slide Pill Swallowing Aid forte
- Primary DI
- 00015482100025
- Version / Model
- 1000002
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-28
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 8023219d-6f53-4228-9636-04bd95a3d255
- Distribution End Date
- 2023-09-19
Device Description
Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.)
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| NXB | Dispenser, Solid Medication | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60365 | Pill swallowing lubricant | A substance intended to be directly administered in the oral cavity, or combined with a tablet/capsule prior to oral administration, to facilitate pill deglutition (swallowing). It is available in spray or gel form and formulated to function as a lubricant (e.g., contains glycerol). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20015482100029 | GS1 | Master Shipper | 24 | Not in Commercial Distribution | 2023-09-19 |
| Package | 10015482100022 | GS1 | Case Pack | 4 | Not in Commercial Distribution | 2023-09-19 |
| Primary | 00015482100025 | GS1 |
Customer Contacts
- Phone
- 800-818-8877
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 77 Degrees Fahrenheit