FDA UDI
In Commercial Distribution
🇺🇸 United States
Steripath Micro
DI: 00858366007108
·
Model: 4020-UN-EN
·
Magnolia Medical Technologies, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Steripath Micro
- Primary DI
- 00858366007108
- Version / Model
- 4020-UN-EN
- Catalog Number
- 4020-UN-EN
- Company Name
- Magnolia Medical Technologies, Inc.
- Labeler DUNS
- 078603710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-26
- Public Version
- 1
- Public Version Date
- 2023-02-03
- Public Version Status
- New
- Public Device Record Key
- e5440f45-2145-43a5-8d60-855aecff99cb
Device Description
Steripath Micro, Universal, 20mL Syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44903 | Blood transfer set | A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858366007105 | GS1 | Sales Pack | 10 | In Commercial Distribution | |
| Primary | 00858366007108 | GS1 |