FDA UDI
In Commercial Distribution
🇺🇸 United States
Alaris, Texium
DI: 10885403221705
·
Model: 10012241-0500
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Alaris, Texium
- Primary DI
- 10885403221705
- Version / Model
- 10012241-0500
- Catalog Number
- 10012241-0500
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 6
- Public Version Date
- 2023-08-04
- Public Version Status
- Update
- Public Device Record Key
- 80b4ff5b-5a98-42d2-a3d1-f541495f589d
Device Description
Closed Male Luer
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 |
|---|---|---|---|---|
| ONB | Closed antineoplastic and hazardous drug reconstitution and transfer system | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60538 | Luer/Luer linear connector, single-use | A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403221705 | GS1 | ||||
| Package | 20885403221702 | GS1 | Box | 50 | In Commercial Distribution | |
| Package | 50885403221703 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)854-7128
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223076 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit