SDR Vehicle Kit Refill-OTC
Basic Information
- Brand Name
- SDR Vehicle Kit Refill-OTC
- Primary DI
- M689SDRVSIPOTCREFILL020
- Version / Model
- 2
- Catalog Number
- SDR-VSIP-OTC
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-07
- Public Version
- 1
- Public Version Date
- 2022-06-15
- Public Version Status
- New
- Public Device Record Key
- fb32d032-2c88-4ade-95ef-d5a7b99fd25a
- Distribution End Date
- 9999-06-02
Device Description
31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY - ENGLISH 2.00 1.00EA L-SDR-VSIP-OTC-REFILSDR Vehicle Kit - OTC-Refill Insert 1.00EA 20-001-KOI Sentinel Chest Seal 2.00 1.00EA FCP-01 ETD 1.00EA BPS-47 Blizzard IFAK 1.00EA 95-000-QR-EN MARCH Cover QR Card - English 1.00EA 31-115-QR-EN TMT - ENGLISH 1.00EA 30-212-QR-EN CELOX RAPID B-CON - ENGLISH 1.00EA 20-001-QR-EN SENTINEL CHEST SEAL - ENGLISH 1.00EA 32-150-QR-EN COMPRESSION DRESSING - ENGLISH 1.00EA 04-101-QR-EN EMERGENCY BLANKET - ENGLISH 1.00EA P81-111 Snap Ring, 1/2" ID, Acetal (.55/13.5mm ID) 1.00EA L01-00 33x1 blank polypropylene TT label 1.00EA P81-250-07 Inner Pouch, PA Kit 7x1 1.00EA P59-100 Inner Pouch, Hypothermia Kit 1.00EA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- No
- 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 | M689SDRVSIPOTCREFILL020 | HIBCC |