Medline HCSFFNVAM

GUDID 20193489021407

MASK, NIV, FULL FACE, NONVENT, AAV, MED

MEDLINE INDUSTRIES, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 20193489021407
• NIH Device Record Key: 5f556449-431c-4f84-8409-0ddc2216911c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medline
• Version Model Number: HCSFFNVAM
• Catalog Number: HCSFFNVAM
• Company DUNS: 025460908
• Company Name: MEDLINE INDUSTRIES, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Handle with Care, Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10193489021400 [Primary]
GS1	20193489021407 [Package]; Contains: 10193489021400; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102120

FDA Product Code

• CBK: Ventilator, continuous, facility use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [Medline]

• 30080196778625: MASK,FACE,CONE STYLE,BLUE
• 40080196743422: TOWEL,OR,DSP,NS,GREEN,BULK,100/CS
• 40080196743408: TOWEL,OR,DSP,NS,WHITE,BULK,100/CS
• 40080196366980: TOWEL,OR,DSP,NS,WHITE,BULK,400/CS
• 00080196357126: ANEROID,HAND HELD,NYLON CASE,ORCHID
• 40080196311867: MASK,RESPIRATOR,N95,CONE STYLE,LF
• 00080196310268: THERMOMETER,EAR,W/EASY PROBE RELEASE
• 20080196288400: TOWEL,OR,DSP,ST,GREEN,DLX,XR,4/PK,20PK/C
• 00080196170046: ANEROID,HAND HELD,SPRAGRAP,STETH,R BLUE
• 00080196169910: ANEROID,HAND HELD,DUAL HD,STETH,TEAL
• 00080196061375: MONITOR,BP,SEMI AUTO,DIGITAL,LARGE ADULT
• 00080196061368: MONITOR,BP,AUTO,DIGITAL,LARGE ADULT
• 40080196033417: TRAY,CATHETER,SUCTION,14 FR,2 GLV,MINI
• 00884389182393: THERMOMETER,FOREHEAD,NO TOUCH
• 00884389176750: METER, GLUCOSE, MINI, SINGLE PATIENT USE
• 00884389176743: STRIP, MINI, 50 EA/BX SINGLE PATIENT USE
• 40884389158761: TOWEL,OR,DSP,NS,BLUE,BULK,400/CS
• 00884389128650: CO2 SAMPLING CANNULA,ADLT,GRN,7'O2,7'CO2
• 00884389128629: CO2 SAMPLING CANNULA,ADLT,GRN,7'O2,4"CO2
• 00884389102568: STRIP,EVENCARE G2,600 EA/CS,50 EA/BX
• 00884389102551: METER, GLUCOSE, EVENCARE G2
• 00884389102544: CONTROL,EVENCARE G2 HI LO
• 00884389102407: STARTER KIT, GLUCOSE, EVENCARE G2 1EA
• 40888277323637: TOWEL,OR,DSP,NS,BLUE,LOW-LINT,400/CS
• 40888277193285: GOWN,SURG,XALT,L3,CRTCL CVR,GREEN,XX
• 40888277191861: GOWN,SURG,XALT/BLKD,BASIC CVR,GREEN, XX
• 40888277191854: GOWN,SURG,XALT/BLKD,BASIC CVR,GREEN, L
• 40888277189219: GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L
• 40884389817910: PUMP,MEDLINE,DVT,INTERMITTENT,SPRG HOOKS
• 40884389193304: GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XX
• 40884389193298: GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX
• 40884389193281: GOWN,SURG,XALT,L3,CRTCL CVR,GREEN,L
• 40884389189222: GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL
• 40884389189208: GOWN,SURG,XALT,L4,CRTCL CVR,OBLUE,XL
• 40884389161105: TOWEL,OR,DSP,NS,NATURAL,BULK,100/CS
• 40884389145679: BATTERY,MEDLINE,DVT,INTERMITTENT/SEQNTL
• 40884389145662: TUBING,HEMOFORCE,DVT,SEQUENTIAL,10'
• 40884389145655: TUBING,HEMOFORCE,DVT,SEQUENTIAL,5'
• 40884389145648: TUBING,HEMOFORCE,DVT,INTERMITTENT,10'
• 40884389145624: TUBING,HEMOFORCE,DVT,INTERMITTENT,5'
• 40884389144870: PUMP,MEDLINE,DVT,SEQUENTIAL
• 40884389126357: KIT,EXTENSION,NEW,FOR MEDLITE BED
• 40884389118727: RAIL,SIDE,SPRING LOADED,4 BAR,1 PAIR
• 40884389117270: BED ONLY,4-MOTOR,HI/LOW,34.5"W,LOCK
• 40884389031446: WRAP,CSR,PAPER,24X30
• 40884389030852: CSR WRAP, 30 X 30
• 40884389028057: JACKSON TABLE PAD COVER
• 40884389028040: CHEST PILLOW
• 40080196771333: ANEROID,MOBILE,ADULT CUFF
• 40080196746027: RAIL,HALF SZ,CLAMP ON,SM GAP BAR SPACE