FDA UDI
In Commercial Distribution
🇺🇸 United States
Steripath
DI: 00858366007146
·
Model: 27BD-23UT-EN
·
Magnolia Medical Technologies, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Steripath
- Primary DI
- 00858366007146
- Version / Model
- 27BD-23UT-EN
- Catalog Number
- 27BD-23UT-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
- 2024-01-08
- Public Version
- 1
- Public Version Date
- 2024-01-16
- Public Version Status
- New
- Public Device Record Key
- ad9361c9-3e5b-4e50-a5c6-f346b2b87fc2
Device Description
Steripath Blood Collection System, Sterile Pack, 23G UltraTouch, Long Neck TA
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 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 |
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858366007143 | GS1 | Sales Pack | 10 | In Commercial Distribution | |
| Primary | 00858366007146 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192247 | 000 |