FDA UDI
In Commercial Distribution
🇺🇸 United States
GO IO Intraosseous Start Kit 12/Case
DI: M689GOIO030
·
Model: 03
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GO IO Intraosseous Start Kit 12/Case
- Primary DI
- M689GOIO030
- Version / Model
- 03
- Catalog Number
- GO IO
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-29
- Public Version
- 2
- Public Version Date
- 2024-12-13
- Public Version Status
- Update
- Public Device Record Key
- 4a0a5cc7-592a-45f0-aebd-44fcf21715ef
- Distribution End Date
- 2028-08-01
Device Description
Secure IV and NIO Fixation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OJA | Intravenous Extension Tubing Set | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32172 | Intravenous line stopcock | A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M689GOIO030 | HIBCC |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]