FDA UDI
In Commercial Distribution
🇺🇸 United States
Kronner Side-Kick High Pressure Gas Line Set
DI: 00856589007073
·
Model: HPL1-BL1-V2
·
KRONNER PROTOTYPES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kronner Side-Kick High Pressure Gas Line Set
- Primary DI
- 00856589007073
- Version / Model
- HPL1-BL1-V2
- Company Name
- KRONNER PROTOTYPES, INCORPORATED
- Labeler DUNS
- 091301184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-26
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8c353153-5295-4c8a-9baf-3bee5ac7f27c
Device Description
One set contains: 1 - Branched line with two male luer-lock fittings on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches. 1 - Straight gas line, whit one male luer-lock fitting on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00856589007080 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00856589007073 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130758 | 000 |