FDA UDI
In Commercial Distribution
🇺🇸 United States
Arisure
DI: 00851891007605
·
Model: YM060
·
YUKON MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Arisure
- Primary DI
- 00851891007605
- Version / Model
- YM060
- Catalog Number
- YM060
- Company Name
- YUKON MEDICAL, LLC
- Labeler DUNS
- 963361170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 2
- Public Version Date
- 2025-07-08
- Public Version Status
- Update
- Public Device Record Key
- 7495c7f6-51da-472e-8073-52c5019556c4
Device Description
Arisure Spike Adapter with CML
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42743 | Negative-pressure intravenous line needleless valve-connector | A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20851891007609 | GS1 | Dispenser | 25 | In Commercial Distribution | |
| Primary | 00851891007605 | GS1 | ||||
| Package | 40851891007603 | GS1 | Case | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 919-595-8250
- [email protected]