FDA UDI
In Commercial Distribution
🇺🇸 United States
Interlink
DI: 00382903033768
·
Model: 303376
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Interlink
- Primary DI
- 00382903033768
- Version / Model
- 303376
- Catalog Number
- 303376
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 124987988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 1
- Public Version Date
- 2023-08-04
- Public Version Status
- New
- Public Device Record Key
- ba7cd5f9-cbac-414a-b722-5325ab1278f4
Device Description
Bare Cannula
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 |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 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 |
|---|---|---|---|---|---|---|
| Package | 50382903033763 | GS1 | Case | 1000 | In Commercial Distribution | |
| Primary | 00382903033768 | GS1 | ||||
| Package | 30382903033769 | GS1 | Box | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920422 | 000 |