FDA UDI
In Commercial Distribution
🇺🇸 United States
LABEL PRODUCT -CODAN
DI: 10813153028039
·
Model: BC111
·
Codan US Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LABEL PRODUCT -CODAN
- Primary DI
- 10813153028039
- Version / Model
- BC111
- Company Name
- Codan US Corporation
- Labeler DUNS
- 058027475
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 1
- Public Version Date
- 2025-06-09
- Public Version Status
- New
- Public Device Record Key
- 38c01a99-243d-4525-aee9-ab41c5a12938
Device Description
One Way Stopcock with Rotating Male Luer lock
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
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32172 | Intravenous line stopcock | A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10813153028039 | GS1 | ||||
| Package | 00813153028032 | GS1 | MULTIVAC PACKAGING | 1 | In Commercial Distribution |