FDA UDI
In Commercial Distribution
🇺🇸 United States
Drainage Set LiquoGuard 7
DI: 04260277176020
·
Model: 00003501 2351
·
Möller Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Drainage Set LiquoGuard 7
- Primary DI
- 04260277176020
- Version / Model
- 00003501 2351
- Company Name
- Möller Medical GmbH
- Labeler DUNS
- 320405061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 2
- Public Version Date
- 2022-01-10
- Public Version Status
- Update
- Public Device Record Key
- eebfa826-8454-4860-b35e-bf8f86ad6a5c
Device Description
The LiquoGuard 7 tube set consists of a tubing, stop cocks with luer locks, a drainage bag with a reflux valve, adapters to ensure correct insertion into the pump, and a pressure sensor housing with two pressure transducers, a cable for connection to the pump and a sticker to attach the sensor housing to the patient's skin. The tube set is only for use with the LiquoGuard 7.
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59960 | Cerebrospinal fluid pressure regulation system sensor/tubing set | A sterile component of a cerebrospinal fluid pressure regulation system that consists of tubing and integrated mechanical pressure sensor designed to monitor cerebrospinal fluid (CSF) pressure to regulate drainage rate. It is intended to be taped to the patient?s skin at a specified level and connected proximally to a dedicated CSF access device ( e.g., catheter, needle), and distally to a CSF drainage control unit/pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260277176020 | GS1 | ||||
| Package | 04260277176037 | GS1 | 10 | In Commercial Distribution | ||
| Package | 04260277176044 | GS1 | 60 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150898 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry