FDA UDI
In Commercial Distribution
🇺🇸 United States
Acu-Life (HE)
DI: 00079573101988
·
Model: 400198/400198A/HK400198/HK400198A
·
APOTHECARY PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Acu-Life (HE)
- Primary DI
- 00079573101988
- Version / Model
- 400198/400198A/HK400198/HK400198A
- Company Name
- APOTHECARY PRODUCTS, LLC
- Labeler DUNS
- 092312735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 1
- Public Version Date
- 2020-08-10
- Public Version Status
- New
- Public Device Record Key
- 19809616-50de-4b58-bb30-b157bd6069a6
Device Description
ACU-STRAP MOTION BANDS CTN 12/144
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MVV | Device, Acupressure | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58072 | Acupressure wristband | A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. The device is typically an adjustable strap made of medical grade thermoplastic material that includes a mechanical pressure dial (a notched wheel) that can be manually rotated by the user to increase or decrease the applied acupressure. It is intended to alleviate nausea caused by various conditions including pregnancy (morning sickness), motion sickness (travel sickness), post anaesthesia sickness, and chemotherapy sickness. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10079573101985 | GS1 | BAG | 12 | In Commercial Distribution | |
| Primary | 00079573101988 | GS1 | ||||
| Package | 20079573101982 | GS1 | case | 12 | In Commercial Distribution | |
| Package | 20079573000131 | GS1 | bag | 12 | In Commercial Distribution | |
| Package | 10079573000158 | GS1 | case | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]