Primary Device ID | 10850005864445 |
NIH Device Record Key | 4549ca24-c004-4ec5-b018-33121b43a0d6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PME014HPB |
Version Model Number | PME014HPB |
Company DUNS | 042928915 |
Company Name | PATHEN MEDICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8773185421 |
questions@pathen.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850005864448 [Primary] |
GS1 | 10850005864445 [Package] Contains: 00850005864448 Package: [100 Units] In Commercial Distribution |
GS1 | 20850005864442 [Package] Contains: 00850005864448 Package: [50 Units] In Commercial Distribution |
FPA | Set, Administration, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-07-24 |
Device Publish Date | 2019-07-15 |
20850005864640 - PS-84320 | 2019-11-18 20G X 1.88" IV CATHETER PURSAFETY S |
20850005864619 - PS-843242 | 2019-11-13 24GX .56" IV CATHETER PURSAFETY S |
20850005864626 - PS-84326 | 2019-11-13 26GX 56" IV CATHETER PURSAFETY S |
20850005864633 - PS-843262 | 2019-11-13 26GX.75" IV CATHETER PURSAFETY S |
00850005864561 - BASNWS -30/150 | 2019-09-24 Administration Set, NO Spike, 150 Micron Filter, 30cc Syringe |
10850005864605 - BMS-2135.17S | 2019-09-17 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock, |
10850005864575 - BM-2135.17 | 2019-09-13 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock |
10850005864582 - 002231 | 2019-09-13 Extension Set, 6" w/ 3-way stopcock |