FDA UDI
In Commercial Distribution
🇺🇸 United States
Arisure
DI: 00851891007209
·
Model: YM064
·
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
- 00851891007209
- Version / Model
- YM064
- Catalog Number
- YM064
- Company Name
- YUKON MEDICAL, LLC
- Labeler DUNS
- 963361170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 3
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 50c92cb6-a58a-4578-843a-5a02d5e6fbdc
Device Description
Arisure Dry Spike Non-Vented
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 |
|---|---|---|---|---|
| 64997 | Non-ISO80369 formatted bag access spike | A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10851891007206 | GS1 | Dispenser | 25 | Not in Commercial Distribution | 2021-11-10 |
| Primary | 00851891007209 | GS1 | ||||
| Package | 20851891007203 | GS1 | Case | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 919-595-8250
- [email protected]