Medline Industries, Inc. DYNJAAHY34

GUDID 10889942290512

HYPER SYSTM MANO .5L MASK12-LF

MEDLINE INDUSTRIES, INC.

General surgical procedure kit, non-medicated, reusable
Primary Device ID10889942290512
NIH Device Record Key0573ba42-e4ea-4e98-8f9c-b389d27f022f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedline Industries, Inc.
Version Model NumberDYNJAAHY34
Catalog NumberDYNJAAHY34
Company DUNS025460908
Company NameMEDLINE INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-5463
Emailcustomerservice@medline.com
Phone+1(800)633-5463
Emailcustomerservice@medline.com
Phone+1(800)633-5463
Emailcustomerservice@medline.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889942290512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-29

On-Brand Devices [Medline Industries, Inc.]

10889942912155ANGIO PACK
10889942598878KIT,CLN UP/ADBN ASC @ST FRANCS
10889942496198ARTHROGRAM TRAY
10889942439805MATHEWSON PACK
10193489654998VAGINAL DELIVERY PACK-LF
10193489654813SIH TOTAL SHOULDER
10193489654776MHC MAJOR ABDOMINAL DRAPE
10193489654349HHOR LITHOTOMY
10193489654233TOTAL SHOULDER TRENHAILE
10193489654165PODIATRY PACK
10193489654141SUPPLEMENTAL CRANIOTOMY PK-LF
10193489654134MINOR PK-LF
10193489654127CATH LAB PACK-LF
10193489654042NETWORK HAND PACK
10193489654035VASCULAR-LF
10193489654004ARTERIOGRAM PACK-LF
10193489653991CORE BIOPSY PACK
10193489653977MINOR PROCEDURE PACK-LF
10193489653946LAPAROSCOPY CDS
10193489653830NEURO
10193489653809TOTAL SHOULDER
10193489653748ORTHO SPINE
10193489653649FHWC TOTAL KNEE
10193489653625FHWC EXTREMITY PACK
10193489653618FHWC ARTHROSCOPY
10193489653595KNEE ARTHROSCOPY
10193489653588NEURO/SPINE-LF
10193489653571TAVI
10193489653410TOTAL KNEE
10193489653403GENERAL LAPAROSCOPY
10193489653311TOTAL KNEE PACK
10193489653304EAR PACK
10193489653298ANGIOGRAPHY PACK
10193489653274NETWORK CYSTO PACK-LF
10193489653243TOTAL HIP
10193489653236LAMINECTOMY
10193489653212SPINAL SKOKIE
10193489653144HIP PACK MAIN
10193489653120TOTAL KNEE-LF
10193489652963ARTHROSCOPY PACK
10193489652925CATARACT PACK
10193489652918CV-TABLE PT2 PACK
10193489652901CV TABLE PACK
10193489652888CRMC UNIVERSAL PACK-LF
10193489652819ANESTHESIA CIRCUIT-LF
10193489652802SINGLE SHOT EPIDURAL
10193489652796SPINAL TRAY 27G X 3.5
10193489652789PROCEDURAL TRAY
10193489652772SUPPORT TRAY
10193489652758MINOR PROCEDURE

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