FDA UDI
In Commercial Distribution
🇺🇸 United States
Coleman Luer Lock Cap
DI: 00081317023487
·
Model: COL-LLCAP
·
MENTOR TEXAS L.P.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- Coleman Luer Lock Cap
- Primary DI
- 00081317023487
- Version / Model
- COL-LLCAP
- Catalog Number
- COL-LLCAP
- Company Name
- MENTOR TEXAS L.P.
- Labeler DUNS
- 167450993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 5
- Public Version Date
- 2026-03-31
- Public Version Status
- Update
- Public Device Record Key
- 99ce393b-b73f-4ad7-afab-f005d962117c
Device Description
Coleman Luer Lock Cap
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 |
|---|---|---|---|---|
| MUU | System, suction, lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63614 | Luer-formatted protective cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10081317023484 | GS1 | 25 Pouches/Box | 25 | In Commercial Distribution | |
| Primary | 00081317023487 | GS1 | ||||
| Unit of Use | 20081317023481 | GS1 |
Customer Contacts
- Phone
- +1(800)235-5731
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981172 | 000 |