FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 20612479261642
·
Model: 421-SCXT3-10-2000
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- McKesson
- Primary DI
- 20612479261642
- Version / Model
- 421-SCXT3-10-2000
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-10
- Public Version
- 1
- Public Version Date
- 2022-11-18
- Public Version Status
- New
- Public Device Record Key
- 429d3e6c-65a4-4890-9e1c-387daf8fbdfb
Device Description
Cap, Disinfecting for Needle Free Valves, Strip of 10
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 |
|---|---|---|---|---|
| QBP | Cap, Device Disinfectant | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61141 | Luer-formatted disinfection cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30612479261656 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 20612479261642 | GS1 | ||||
| Package | 40612479261660 | GS1 | Case | 8 | In Commercial Distribution | |
| Unit of Use | 10612479265858 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130975 | 000 |