Primary Device ID | H862AFALL2 |
NIH Device Record Key | 4892c196-ec7a-4859-b204-ff7641382b95 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aspiration and Flush Assembly |
Version Model Number | AFA-LL |
Catalog Number | AFA-LL |
Company DUNS | 192559557 |
Company Name | URESIL, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com | |
Phone | 1-800-538-7374 |
sales@uresil.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H862AFALL0 [Primary] |
HIBCC | H862AFALL1 [Package] Contains: H862AFALL0 Package: Dispenser [5 Units] In Commercial Distribution |
HIBCC | H862AFALL2 [Package] Contains: H862AFALL1 Package: Shipper [5 Units] In Commercial Distribution |
GBO | Catheter, Nephrostomy, General & Plastic Surgery |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-03-25 |
Device Publish Date | 2016-08-29 |
H862AFA20P2 | ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL |
H862UFALL2 | Universal Funnel Adapter-Luer Lock |
H862DFALL2 | ASPIRATION FLUSH ADAPTER – DOUBLE CLAMP |
H862AFALL2 | ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM |
H862AFALB2 | ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM |
20817640020817 | Universal Funnel Adapter-Luer Lock |
10817640020209 | ASPIRATION FLUSH ADAPTER – DOUBLE CLAMP |
10817640020117 | ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM |
10817640020100 | ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM |