FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaSafe
DI: 20885403238564
·
Model: 9391-0300
·
CAREFUSION 303, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- VersaSafe
- Primary DI
- 20885403238564
- Version / Model
- 9391-0300
- Catalog Number
- 9391-0300
- Company Name
- CAREFUSION 303, INC.
- Labeler DUNS
- 360624720
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2020-04-27
- Public Version Status
- Update
- Public Device Record Key
- 509a1063-d932-4ba2-859c-daaf834ad4f5
Device Description
VersaSafe Locking Blunt Cannula 11 Gauge
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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42631 | Split-septum needleless valve-connector | A small, sterile, stand-alone, needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position, and through which IV access is gained via blunt cannula separation of a septum. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403238565 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 20885403238564 | GS1 | ||||
| Unit of Use | 10885403238567 | GS1 |
Customer Contacts
- Phone
- +1(800)854-7128
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit