FDA UDI
In Commercial Distribution
🇺🇸 United States
DualCap®
DI: 10884450309367
·
Model: 10884450309367
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
350
Basic Information
- Brand Name
- DualCap®
- Primary DI
- 10884450309367
- Version / Model
- 10884450309367
- Catalog Number
- 500-LB/A
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 350
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 21fe81cf-0658-4e15-84e7-b90bb21e981c
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
- Yes
- 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 |
|---|---|---|---|---|
| LKB | Pad, alcohol, device disinfectant | Unknown | U |
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 | 20884450309364 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 10884450309367 | GS1 | ||||
| Unit of Use | 00884450309360 | GS1 |