FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard
DI: 00842289100237
·
Model: D9-2004MG
·
MEDISYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard
- Primary DI
- 00842289100237
- Version / Model
- D9-2004MG
- Company Name
- MEDISYSTEMS CORPORATION
- Labeler DUNS
- 061310132
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2021-02-22
- Public Version Status
- Update
- Public Device Record Key
- 37963225-f7ec-474e-9f63-8ad2fd1f1b5b
- Distribution End Date
- 2020-12-31
Device Description
MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD Total Case Qty 250 (120 Twin pouches + 10 Single pouches)
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 |
|---|---|---|---|---|
| FIE | Needle, Fistula | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12741 | Haemodialysis needle | A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842289100237 | GS1 |
Customer Contacts
- Phone
- 1-866-697-8243
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1 | Inch | |
| Needle Gauge | 14 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius