FDA UDI
In Commercial Distribution
🇺🇸 United States
Procedure Products Lines
DI: B160B48F0711
·
Model: B48-F071
·
PROCEDURE PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Procedure Products Lines
- Primary DI
- B160B48F0711
- Version / Model
- B48-F071
- Company Name
- PROCEDURE PRODUCTS, INC.
- Labeler DUNS
- 151507563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-15
- Public Version
- 1
- Public Version Date
- 2018-07-16
- Public Version Status
- New
- Public Device Record Key
- 81d8ff79-5268-4c3d-b009-a8988d7316bb
Device Description
Fixed, braided, high-pressure connector
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 |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18067 | Intravenous line recessed-needle connector | A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B160B48F0711 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914128 | 000 |