FDA UDI
In Commercial Distribution
🇺🇸 United States
Beeline motIV
DI: 00857362007228
·
Model: SK2
·
Rex Pj Tech LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Beeline motIV
- Primary DI
- 00857362007228
- Version / Model
- SK2
- Company Name
- Rex Pj Tech LLC
- Labeler DUNS
- 096931706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-04
- Public Version
- 2
- Public Version Date
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- a99ab946-e69f-4414-ab46-91ec8a7bbaee
Device Description
Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRN | Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62713 | Prefilled mechanical infusion pump/catheter | A device intended to be used in a clinical setting for continuous localized infusion of a dose of analgesic medication (e.g., ropivacaine), using a non-electric/non-elastic mechanical infusion pump, for regional anaesthesia and postoperative pain management. It consists of a mechanical infusion pump prefilled with medication, tubing line, and infusion catheter. The infusion catheter is intended to be inserted into the wound site during surgery and connected to the pump via the tubing line for infusion of the drug. The pump can be worn by the patient during the treatment course. The device is discarded when the medication is exhausted (single-use). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10857362007225 | GS1 | cardboard box | 12 | In Commercial Distribution | |
| Primary | 00857362007228 | GS1 |