FDA UDI
In Commercial Distribution
🇺🇸 United States
RxCrush
DI: 00850006611126
·
Model: EL02-100
·
RESOLVE DESIGNS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RxCrush
- Primary DI
- 00850006611126
- Version / Model
- EL02-100
- Catalog Number
- EL02
- Company Name
- RESOLVE DESIGNS LLC
- Labeler DUNS
- 091290281
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-17
- Public Version
- 1
- Public Version Date
- 2024-12-25
- Public Version Status
- New
- Public Device Record Key
- 9ffe1dcd-e8a1-41b3-bc72-141f9924cf17
Device Description
Female ENFit to Female Luer Lock Adapter - Screw-on. Connects male ENFit (e.g. RxCrush Pouch) to male Luer syringe.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64470 | ENFit/Luer linear connector | A small, non-powered, noninvasive, tubular, two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850006611120 | GS1 | Box | 1000 | In Commercial Distribution | |
| Primary | 00850006611126 | GS1 | ||||
| Package | 10850006611123 | GS1 | SAMPLE | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 877.343.2783
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight. Keep out of moisture.