NIO Adult Intraosseous Access Device (12 years and over)
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| NSN | 6515-01-667-2884 |
|---|---|
| Manufacturer | PerSys Medical (Safeguard Medical) |
| Model | NIO Adult, 15G x 25 mm |
| Kilmės šalis | USA |
| Gaminio tipas | Medical device |
| Features | 15G, 25 mm needle; automatic deployment; access in less than 10 seconds; no exposed needle; protection against accidental activation; 5-year shelf life. |
| Certificates | FDA 510(k) K142086, ISO 13485 |
| Sterility | Sterile |
| Expiration date | 5 years |
| Usage | Emergency vascular access for adults and children aged 12 years and older when intravenous access cannot be established or is not feasible. Single-use. |
| Warnings | For use by trained healthcare professionals only. Do not use in a fractured or infected bone, or in a limb where intraosseous access has already been attempted. |
| Storage | Store in a dry place at room temperature in the original packaging. |
| Product dimensions | 13,9 × 5,7 × 2,7 cm |
| Spalva | Mėlyna |
| Equipment / Configuration | 1 × sterile NIO Adult™ device, 1 × NIO Fixation™ securement dressing, instructions for use. |
NIO Infant Intraosseous Access Device
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| Manufacturer | PerSys Medical (Safeguard Medical) |
|---|---|
| Model | NIO Infant, stepped needle 14G–18G |
| Kilmės šalis | USA |
| Gaminio tipas | Medical device |
| Features | Stepped 14G–18G needle; tactile feedback indicating position within the bone marrow cavity; self-contained device; no exposed needle. |
| Certificates | FDA 510(k) (K190538), ISO 13485 |
| Sterility | Sterile |
| Expiration date | 5 years. |
| Usage | Emergency vascular access in infants when intravenous access cannot be established or is not feasible. |
| Warnings | Intended for use by trained healthcare professionals only. Do not use on fractured or infected bone. |
| Storage | Store in a dry place at room temperature in the original packaging. |
| Product dimensions | 11,7 × 4,3 × 3,3 cm. |
| Equipment / Configuration | 1 × sterile NIO Infant™ device, 1 × Fixation Dressing securement dressing, instructions for use. |
NIO Pediatric Intraosseous Access Device
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| Manufacturer | PerSys Medical (Safeguard Medical) |
|---|---|
| Model | NIO Pediatric, 18G |
| Kilmės šalis | USA |
| Gaminio tipas | Medical device |
| Features | Paediatric-specific needle; automatic deployment; no exposed needle; self-contained device requiring no additional drill. |
| Certificates | FDA 510(k) K191258, ISO 13485 |
| Sterility | Sterile |
| Expiration date | 5 years. |
SAM IO Intraosseous Needle 15G x 15 mm
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| NSN | 6515-01-694-6069 |
|---|---|
| Manufacturer | SAM Medical Products |
| Model | SAM IO Needle 15G × 15 mm, 1-Pack |
| Kilmės šalis | USA |
| Gaminio tipas | Medical device |
| Features | 15G gauge; 15 mm length; compatible with the SAM IO Driver; standard Luer-Lock connection; supplied individually (1 unit). |
| Certificates | FDA 510(k) K191488; registered in the FDA GUDID. |
| Sterility | Sterile |
| Expiration date | 5 years. |
| Usage | Additional or replacement needle for the SAM IO system when the soft tissue layer is thin. |
| Warnings | Single-use device. Intended for use by trained healthcare professionals only. |
| Storage | Store in a dry place at room temperature in the original packaging. |
| Product dimensions | 15G, 15 mm. |
| Equipment / Configuration | 1 needle |