| Primary Device ID | 10889942614875 |
| NIH Device Record Key | 21c3c3d2-07a8-4c82-8c19-d62c36917c63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medline Industries, Inc. |
| Version Model Number | DYKE1486 |
| Catalog Number | DYKE1486 |
| Company DUNS | 025460908 |
| Company Name | MEDLINE INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889942614875 [Primary] |
| NWR | Kit, catheter, foley (excludes HIV testing) |
| NWU | Endoscope introducer kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-28 |
| Device Publish Date | 2018-08-28 |
| 10889942912155 | ANGIO PACK |
| 10889942598878 | KIT,CLN UP/ADBN ASC @ST FRANCS |
| 10889942496198 | ARTHROGRAM TRAY |
| 10889942439805 | MATHEWSON PACK |
| 10193489654998 | VAGINAL DELIVERY PACK-LF |
| 10193489654813 | SIH TOTAL SHOULDER |
| 10193489654776 | MHC MAJOR ABDOMINAL DRAPE |
| 10193489654349 | HHOR LITHOTOMY |
| 10193489654233 | TOTAL SHOULDER TRENHAILE |
| 10193489654165 | PODIATRY PACK |
| 10193489654141 | SUPPLEMENTAL CRANIOTOMY PK-LF |
| 10193489654134 | MINOR PK-LF |
| 10193489654127 | CATH LAB PACK-LF |
| 10193489654042 | NETWORK HAND PACK |
| 10193489654035 | VASCULAR-LF |
| 10193489654004 | ARTERIOGRAM PACK-LF |
| 10193489653991 | CORE BIOPSY PACK |
| 10193489653977 | MINOR PROCEDURE PACK-LF |
| 10193489653946 | LAPAROSCOPY CDS |
| 10193489653830 | NEURO |
| 10193489653809 | TOTAL SHOULDER |
| 10193489653748 | ORTHO SPINE |
| 10193489653649 | FHWC TOTAL KNEE |
| 10193489653625 | FHWC EXTREMITY PACK |
| 10193489653618 | FHWC ARTHROSCOPY |
| 10193489653595 | KNEE ARTHROSCOPY |
| 10193489653588 | NEURO/SPINE-LF |
| 10193489653571 | TAVI |
| 10193489653410 | TOTAL KNEE |
| 10193489653403 | GENERAL LAPAROSCOPY |
| 10193489653311 | TOTAL KNEE PACK |
| 10193489653304 | EAR PACK |
| 10193489653298 | ANGIOGRAPHY PACK |
| 10193489653274 | NETWORK CYSTO PACK-LF |
| 10193489653243 | TOTAL HIP |
| 10193489653236 | LAMINECTOMY |
| 10193489653212 | SPINAL SKOKIE |
| 10193489653144 | HIP PACK MAIN |
| 10193489653120 | TOTAL KNEE-LF |
| 10193489652963 | ARTHROSCOPY PACK |
| 10193489652925 | CATARACT PACK |
| 10193489652918 | CV-TABLE PT2 PACK |
| 10193489652901 | CV TABLE PACK |
| 10193489652888 | CRMC UNIVERSAL PACK-LF |
| 10193489652819 | ANESTHESIA CIRCUIT-LF |
| 10193489652802 | SINGLE SHOT EPIDURAL |
| 10193489652796 | SPINAL TRAY 27G X 3.5 |
| 10193489652789 | PROCEDURAL TRAY |
| 10193489652772 | SUPPORT TRAY |
| 10193489652758 | MINOR PROCEDURE |