FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Aspiration and Flush Assembly
DI: H862AFALB0
·
Model: AFA-LB
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Aspiration and Flush Assembly
- Primary DI
- H862AFALB0
- Version / Model
- AFA-LB
- Catalog Number
- AFA-LB
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 6
- Public Version Date
- 2025-09-30
- Public Version Status
- Update
- Public Device Record Key
- 7ce9818c-5798-4be0-9532-99a3eb87eccf
- Distribution End Date
- 2025-09-30
Device Description
ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
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
- Yes
- 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 |
|---|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64467 | Luer/non-ISO80369-standardized linear connector, single-use | A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H862AFALB2 | HIBCC | Shipper | 5 | Not in Commercial Distribution | 2025-09-30 |
| Package | H862AFALB1 | HIBCC | Dispenser | 5 | Not in Commercial Distribution | 2025-09-30 |
| Primary | H862AFALB0 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]