FDA UDI
In Commercial Distribution
🇺🇸 United States
iCare Vacuum Cupping Set
DI: 00818318025352
·
Model: CC200
·
Prime Holly Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
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Basic Information
- Brand Name
- iCare Vacuum Cupping Set
- Primary DI
- 00818318025352
- Version / Model
- CC200
- Catalog Number
- CC200
- Company Name
- Prime Holly Corporation
- Labeler DUNS
- 080445043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-05-16
- Public Version
- 1
- Public Version Date
- 2025-05-26
- Public Version Status
- New
- Public Device Record Key
- 109f3917-a094-4816-a0f5-f41c782833f1
Device Description
iCare Vacuum Cupping Set
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNM | Device, Pressure Applying | Physical Medicine | 890.5765 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45164 | Cupping therapy device | A dome typically made of glass or hard plastic intended to be used to manually produce sites of suction on the surface of the skin, or other soft tissues, in the practice of cupping therapy used by acupuncture and traditional Chinese medicine practitioners for localized healing or energy flow. The device is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818318029081 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00818318025352 | GS1 | ||||
| Unit of Use | 20818318029088 | GS1 |
Customer Contacts
- Phone
- 4085739889
- [email protected]