PMI PMIS2035

GUDID 10812608020024

PMI Straight Huber Needle w/Female Luer Connector 20G x 3 ½"

PROGRESSIVE MEDICAL, INC.

Subcutaneous injection/infusion port needle
Primary Device ID10812608020024
NIH Device Record Keyf8eb6711-81e0-4e60-b82f-64e7b2644838
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMI
Version Model NumberPMIS2035
Catalog NumberPMIS2035
Company DUNS192135242
Company NamePROGRESSIVE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM
Phone314-961-5786
EmailCS@PROGRESSIVEMEDINC.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100812608020027 [Primary]
GS110812608020024 [Package]
Contains: 00812608020027
Package: 12 [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [PMI]

00812608021840PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 100" le
00812608021826PMI Pharmacy Pump Set, dual tubing with spikes & luer lock distal ends
00812608021765PMI IV Start Kit
00812608021741PMI Disposable Operative Cholangiogram Catheter 20" for percutaneous insertion
10812608021724PMI Empty IV Bag 150 mL; 2 ports
10812608021700PMI Empty IV Bag 1000mL; 2 ports
00812608021680PMI Empty IV Bag 500mL; 2 ports
00812608021666PMI Empty IV Bag 250mL; 2 ports
00812608021635PMI Empty IV Bag 100mL; 2 ports
00812608021604PMI Empty IV Bag 50mL; 2 ports
10812608021588PMI Cholangiogram Grasper Stainless Steel Replacement Cap - Reusable
10812608021571PMI Extractor-EZ is a disposable instrument with a retractable blade designed to enlarge the fas
00812608021550PMI Cholangiogram Combo Pack Includes: (PMIXL11) Disposable Operative Cholangiogram Catheter 11
00812608021536PMI Cholangiogram Combo Pack Includes: Disposable Operative Cholangiogram Catheter 20" and (PMI
00812608021499PMI Insufflation Needle 150mm (14 ga)
00812608021475PMI Insufflation Needle 120mm (14ga)
00812608021451PMI LATEX FREE DRESSING CHANGE KIT WITH CHLORAPREP
00812608021437LACERATION TRAY W/SERRATED FORCEP
00812608021413PMI IV START KIT W/CHLORAPREP LATEX FREE
00812608021390PMI IV START KIT W/ PVP LATEX FREE
00812608021376PMI Cholangiogram Grasper, Standard
00812608021338PMI Pharmacy pump set, straight with spike and luer lock distal end
00812608021314PMI Cholangiogram Grasper, Bariatric
00812608021307PMI IV admin set with flow regulator, 100" length, 20 drop, 15 micron filter in drip chamber, ro
10812608021281PMI Huber Safety Infusion Set 22G x 1 ½” Needle, Needle-Free Y-Site, 8" tub
10812608021274PMI Huber Safety Infusion Set 22G x 1” Needle, Needle-Free Y-Site, 8" tubin
10812608021267PMI Huber Safety Infusion Set 20G x 1 ½” Needle, Needle-Free Y-Site, 8" tubing
10812608021250PMI Huber Safety Infusion Set 20G x 1” Needle, Needle-Free Y-Site, 8" tubing
10812608021243PMI Huber Safety Infusion Set 19G x ¾” Needle, Needle-Free Y-Site, 8" tubing
10812608021236PMI Huber Safety Infusion Set 19G x 1 ½” Needle, Needle-Free Y-Site, 8" tub
10812608021229PMI Huber Safety Infusion Set 19G x 1” Needle, Needle-Free Y-Site, 8" tubin
10812608021168PMI Huber Safety Infusion Set 22G x ½” Needle, 6" tubing
10812608021151PMI Huber Safety Infusion Set 22G x ¾” Needle, 6" tubing
10812608021144PMI Huber Safety Infusion Set 22G x 1 ½” Needle, 6" tubing
00812608021130PMI Huber Safety Infusion Set 22G x 1” Needle, 6" tubing
10812608021120PMI Huber Safety Infusion Set 20G x ½" Needle, 6" Tubing
10812608021113PMI Huber Safety Infusion Set 19G x ¾” Needle, 6" tubing
10812608021106PMI Huber Safety Infusion Set 19G x 1 ½” Needle, 6" tubing
10812608021090PMI Huber Safety Infusion Set 19G x 1” Needle, 6" tubing
10812608021083PMI Huber Safety Infusion Set, 20G x 1 ½” Needle, 6" tubing
10812608021076PMI Huber Safety Infusion Set 22G x ¾” Needle, Needle-Free Y-Site, 8" Tubin
10812608021069PMI Operative Cholangiogram Catheter; tubing is 76cm in length, 16ga with a
10812608021052PMI Disposable Puncture Closure Device / Suture Grasper
10812608021045PMI Pneumoperitoneum Insufflation Needle 12cm
10812608021038PMI Disposable Percutaneous Introducer (4” length- 14g);
10812608021021PMI Disposable Cholangiogram Catheter 13"; for port insertion
10812608021014PMI Disposable Cholangiograph Catheter 7", for traditional open procedure
10812608021007PMI Disposable Cholangiogram Catheter 11"; for percutaneous insertion
10812608020994PMI Combo Pack Includes: Disposable Lap Cholangiography Catheter (PMIXL11)
10812608020987For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram C

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.