FDA UDI
In Commercial Distribution
🇺🇸 United States
RediCap
DI: 00732671005816
·
Model: 581
·
AMITY HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- RediCap
- Primary DI
- 00732671005816
- Version / Model
- 581
- Catalog Number
- 581
- Company Name
- AMITY HOLDINGS, LLC
- Labeler DUNS
- 016069284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-10
- Public Version
- 3
- Public Version Date
- 2020-08-18
- Public Version Status
- Update
- Public Device Record Key
- 5e9534da-1ede-4672-b89f-03d7729292a4
- Distribution End Date
- 2025-07-10
Device Description
Tamper Evident Syringe Cap
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63614 | Luer-formatted protective cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10732671105810 | GS1 | Blister Pack | 2 | In Commercial Distribution | 2025-07-10 |
| Primary | 00732671005816 | GS1 | ||||
| Package | 20732671205814 | GS1 | Chipboard Carton | 250 | In Commercial Distribution | 2025-07-10 |
| Package | 30732671305818 | GS1 | Corrugate Carton | 4 | In Commercial Distribution | 2025-07-10 |
Customer Contacts
- Phone
- 800 327 8894
- [email protected]