FDA UDI
In Commercial Distribution
🇺🇸 United States
Hello Cake - Tush Cush 1.7 fl. oz. / 50mL
DI: 00850017395046
·
Model: 39504
·
Hello Cake, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Hello Cake - Tush Cush 1.7 fl. oz. / 50mL
- Primary DI
- 00850017395046
- Version / Model
- 39504
- Company Name
- Hello Cake, Inc.
- Labeler DUNS
- 117536472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- 1656fa8a-99f7-4e20-b583-81850ec473d5
Device Description
Tush Cush - A hybrid lubricant for backside play
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
- No
- 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 |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. 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 | 00850017395817 | GS1 | shipping case | 12 | In Commercial Distribution | |
| Primary | 00850017395046 | GS1 | ||||
| Package | 40850017395846 | GS1 | inner shipper | 4 | In Commercial Distribution | |
| Package | 20850017395040 | GS1 | unit carton | 1 | In Commercial Distribution |