iTClamp Haemorrhage Control Device
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| NSN | 6515-01-629-7044 |
|---|---|
| Manufacturer | Innovative Trauma Care, Inc. |
| Model | iTClamp 50 |
| Kilmės šalis | USA |
| Gaminio tipas | Medical device |
| Features | Applied in approximately 10 seconds; maintains pressure hands-free; suitable for junctional areas; FDA 510(k) cleared; CE marked since 2013. |
| Certificates | FDA 510(k) clearance; FDA 21 CFR 870.4450 / DXC |
| Sterility | Sterile |
| Expiration date | 6 years |
| Usage | Wounds to the head, neck, axilla, groin, and extremities — particularly in areas where a tourniquet cannot be applied. |
| Warnings | For use by trained professionals only. Not suitable for wounds in the eye area. The device should be removed by a healthcare professional. |
| Storage | Store in a dry place in the original packaging. |
| Product dimensions | 2,24″ × 1,98″ × 1,13″, t. y.56,9 × 50,3 × 28,7 mm. |
| Spalva | Skaidri |
| Equipment / Configuration | 1 × sterile iTClamp® 50 bleeding control device in individual sterile packaging. |
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. |