FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Camino®
DI: 10381780122012
·
Model: FLEXADR
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Camino®
- Primary DI
- 10381780122012
- Version / Model
- FLEXADR
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-29
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- d48acb45-01a2-4746-8037-df729fbbd854
- Distribution End Date
- 2020-04-01
Device Description
The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino Flex Catheters (Integra LifeSciences Corporation) with the Camino Advanced Monitor (CAM01) for the direct and continuous measurement of intracranial pressure (ICP). It is a reusable device with an accessory holder which allows the Integra Camino Flex Adapter to be permanently attached to the Camino Advanced Monitor.
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780122012 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121159 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 150mm width x 350mm height x 30mm depth, 0.5kg (1.1lbs) weight |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature: 0°C (+32°F) to +50°C (+122°F). Relative Humidity, non-condensing: +20% to +95%. Pressure: +500hPa to +1060hPa.