FDA UDI
In Commercial Distribution
🇺🇸 United States
Chinook IDPA Individual Direct Pressure Adjunct
DI: 00850018892872
·
Model: 05323
·
Altitude Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chinook IDPA Individual Direct Pressure Adjunct
- Primary DI
- 00850018892872
- Version / Model
- 05323
- Company Name
- Altitude Technologies Inc.
- Labeler DUNS
- 621904622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-30
- Public Version
- 1
- Public Version Date
- 2023-11-07
- Public Version Status
- New
- Public Device Record Key
- d5c1cb3d-b747-400c-9abe-369b544b4a97
Device Description
The (IDPA) Individual Direct Pressure Adjunct is a user-friendly device used in the prehospital setting to provide rapid arterial occlusion of an extremity by providing direct pressure over an artery or wound. This device is a small, lightweight, versatile device that is inexpensive and portable which will enable it to reach those within the field that really need it.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44047 | First aid kit, non-medicated, single-use | A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018892872 | GS1 |