FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Apheresis Needle with MASTERGUARD™ Protector
DI: 00811137012435
·
Model: 4R2440
·
FENWAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Apheresis Needle with MASTERGUARD™ Protector
- Primary DI
- 00811137012435
- Version / Model
- 4R2440
- Catalog Number
- 4R2440
- Company Name
- FENWAL, INC.
- Labeler DUNS
- 794519020
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2020-07-10
- Public Version Status
- Update
- Public Device Record Key
- cc6ba833-e0f1-431e-8ccd-c8dd5cdcbb2b
- Distribution End Date
- 2020-06-09
Device Description
Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path.
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 |
|---|---|---|---|---|
| FIE | Needle, Fistula | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47572 | Apheresis system tubing set | A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811137012435 | GS1 | ||||
| Package | 10811137012432 | GS1 | Case | 250 | Not in Commercial Distribution | 2020-06-09 |