FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stradis Medical, LLC
DI: M7521000171
·
Model: 100017
·
STRADIS MEDICAL, LLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Stradis Medical, LLC
- Primary DI
- M7521000171
- Version / Model
- 100017
- Company Name
- STRADIS MEDICAL, LLC
- Labeler DUNS
- 174262477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-08
- Public Version
- 3
- Public Version Date
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- 4671a701-54a5-4b28-ac64-f9c4e69d826a
- Distribution End Date
- 2023-02-09
Device Description
Infusion Kit O
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 | M7521000175 | HIBCC | outer box | 50 | Not in Commercial Distribution | 2023-02-09 |
| Primary | M7521000171 | HIBCC |
Customer Contacts
- Phone
- 1-800-424-8520
- [email protected]