FDA UDI
Not in Commercial Distribution
🇺🇸 United States
12 uPAT Probes for Watch-PAT200U
DI: 07290109222011
·
Model: 12 uPAT Probes for Watch-PAT200U
·
ITAMAR MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 12 uPAT Probes for Watch-PAT200U
- Primary DI
- 07290109222011
- Version / Model
- 12 uPAT Probes for Watch-PAT200U
- Catalog Number
- AC2101200
- Company Name
- ITAMAR MEDICAL LTD
- Labeler DUNS
- 531857076
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 4
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- 05949858-3618-47d7-8754-4fe59292c4a3
- Distribution End Date
- 2023-10-15
Device Description
12 uPAT Probes
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNR | Ventilatory Effort Recorder | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47686 | Cardiovascular-risk peripheral arterial tonometry system sensor | An pneumo-electronic device, typically designed as a proximal annular cuff incorporating plethysmography-based pneumatic bio-sensor, that is placed on a patient's finger during a reactive hyperemia test for the assessment of endothelial dysfunction (poor vasodilatory response) and arterial stiffness. It is connected to the cardiovascular-risk peripheral arterial tonometry system data processor and imparts a uniform pressure field to the distal two thirds of the finger, including the tip, to measure arterial pulsatile volume changes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109222011 | GS1 |
Customer Contacts
- Phone
- +97246177000
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 68.947 – 103.42 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 68.947 – 103.42 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius