Identity
- Trade Name
- ShippertTech FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe. FDA UDI
- Model / Reference
- IO Needle Safety Sheath FDA UDI
- Description
- The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe. FDA UDI
Identifiers
- Catalog Number
- 5-IOSS-US FDA UDI
- Primary DI / UDI-DI
- 00850458007058 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraosseous infusion kit
ShippertTech by Actuated Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraosseous infusion kit.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- RENOVA SPINE BONE FILLER — BIOPSYBELL SRL · Class IIa
- Spinertome kit — Adria S.r.l. · Class IIb
- Cook — COOK INCORPORATED · Class II
- RENOVA SPINE KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
- SPASY — Seawon Meditech Co.,Ltd. · Class IIa
- VERTEMAX KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Actuated Medical, Inc.
Sources (1)
- FDA UDI 5216aaeb-d5bd-4d34-8f03-8065fe184b9f 34 fields · synced May 30, 2026