FDA UDI
In Commercial Distribution
🇺🇸 United States
Molded Products, Inc.
DI: B144MPC115LB100
·
Model: MPC-115LB-10
·
MOLDED PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
10
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Basic Information
- Brand Name
- Molded Products, Inc.
- Primary DI
- B144MPC115LB100
- Version / Model
- MPC-115LB-10
- Catalog Number
- MPC-115LB-10
- Company Name
- MOLDED PRODUCTS, INC.
- Labeler DUNS
- 157506015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-09-04
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- c6246c98-951e-481f-9a6f-bf9ca6c01a13
Device Description
Female Luer Lock - Lt. Blue, 10 pcs. per bag
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
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 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 | B144MPC115LB103 | HIBCC | Case | 25 | In Commercial Distribution | |
| Package | B144MPC115LB102 | HIBCC | Box | 2 | In Commercial Distribution | |
| Package | B144MPC115LB101 | HIBCC | Bag | 100 | In Commercial Distribution | |
| Primary | B144MPC115LB100 | HIBCC | ||||
| Unit of Use | B144MPC115LB0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925927 | 000 |