FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Safe-T
DI: 10885403229008
·
Model: 4306CWSP
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Safe-T
- Primary DI
- 10885403229008
- Version / Model
- 4306CWSP
- Catalog Number
- 4306CWSP
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-31
- Public Version
- 5
- Public Version Date
- 2023-12-26
- Public Version Status
- Update
- Public Device Record Key
- a8b4b717-6d24-4e0f-b5ac-618e435e8097
- Distribution End Date
- 2023-12-26
Device Description
Safe-T PLUS Adult Lumbar Puncture Tray, 22 G x 3 1/2 Inch BD Whitacre Spinal Needle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PWY | Lumbar puncture tray (adult & pediatric) | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12404 | Lumbar puncture kit | A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403229006 | GS1 | Case | 10 | Not in Commercial Distribution | 2023-12-26 |
| Primary | 10885403229008 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius