FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Streamline Airless System Set with Locksite Needleless Access Sites
DI: M535SL2050M20550
·
Model: SL-2050M2055
·
NXSTAGE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Streamline Airless System Set with Locksite Needleless Access Sites
- Primary DI
- M535SL2050M20550
- Version / Model
- SL-2050M2055
- Company Name
- NXSTAGE MEDICAL, INC.
- Labeler DUNS
- 088013219
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 4
- Public Version Date
- 2020-09-29
- Public Version Status
- Update
- Public Device Record Key
- 4353d1a2-013d-4e60-ac9d-7a7daf7f658b
- Distribution End Date
- 2020-09-28
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 |
|---|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34999 | Haemodialysis blood tubing set, single-use | A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M535SL2050M20555 | HIBCC | 32 | Not in Commercial Distribution | 2020-09-28 | |
| Primary | M535SL2050M20550 | HIBCC |
Customer Contacts
- Phone
- 1-866-697-8243
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from moisture, freezing and excessive heat
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius