FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04046964317729
·
Model: 622320
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- NA
- Primary DI
- 04046964317729
- Version / Model
- 622320
- Catalog Number
- 622320
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- bd045af8-4656-4004-aca7-aab94457e604
- Distribution End Date
- 2020-06-01
Device Description
HP20-FM 20" HP INJECTION LINE
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXT | INJECTOR AND SYRINGE, ANGIOGRAPHIC | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44685 | Radiographic procedure tubing | A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964317729 | GS1 | ||||
| Unit of Use | 04046964317705 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]