FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl
DI: M535SL2000M2095L0
·
Model: SL-2000M2095L
·
MEDISYSTEMS CORPORATION
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 and SecureCl
- Primary DI
- M535SL2000M2095L0
- Version / Model
- SL-2000M2095L
- Company Name
- MEDISYSTEMS CORPORATION
- Labeler DUNS
- 061310132
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 4
- Public Version Date
- 2020-09-29
- Public Version Status
- Update
- Public Device Record Key
- 33c54fc7-f149-40c6-b2fe-ac310e729a07
- 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 | M535SL2000M2095L5 | HIBCC | 32 | Not in Commercial Distribution | 2020-09-28 | |
| Primary | M535SL2000M2095L0 | 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
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius