FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Healthcare Systems Inc.
DI: 00811870030109
·
Model: B9-8598
·
Manus Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Custom Healthcare Systems Inc.
- Primary DI
- 00811870030109
- Version / Model
- B9-8598
- Company Name
- Manus Medical, LLC
- Labeler DUNS
- 800604196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-29
- Public Version
- 3
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 6996d6e3-75c9-49b7-a273-a184b7fbe2b2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGJ | Nerve Block Tray | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45694 | Ventriculoperitoneal shunt | An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20811870030103 | GS1 | N/A | 50 | In Commercial Distribution | |
| Primary | 00811870030109 | GS1 |