FDA UDI
In Commercial Distribution
🇺🇸 United States
Dispensing Pin
DI: 04046964183195
·
Model: 413504
·
B. BRAUN MEDICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Dispensing Pin
- Primary DI
- 04046964183195
- Version / Model
- 413504
- Catalog Number
- 413504
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- ede0cdf5-c986-4965-8e72-bd9428057b6c
Device Description
MINI-SPIKE® Dispensing Pin with ULTRASITE® Valve and Security Clip
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
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
| LHI | Set, i.V. Fluid transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64996 | Luer-formatted bag access spike | A small, noninvasive, tubular connector with a Luer connection (either lock or slip) at one end, and a hollow spike (either blunt or sharp) at the other end, intended to connect an intravenous (IV) fluid or blood bag to a fluid line or syringe for administration to a patient; it may in addition be used to draw medication from a vial, however it is not a vial/bottle adaptor. It may include an additional administration port (i.e., Y-site device), a built-in air filter, retention clamp, or valve(s); it does not however include tubing (i.e., not a tubing set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964183195 | GS1 | ||||
| Unit of Use | 04046964183188 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]