HUDSON RCI HUD717301

GUDID 20197344007698

SPIROMETER,INCENTIVE,TRIFLO II,EXERCISER

MEDLINE INDUSTRIES, INC.

Incentive spirometer

• Primary Device ID: 20197344007698
• NIH Device Record Key: cd9a903d-2712-4300-92cd-a93d731fa0ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUDSON RCI
• Version Model Number: HUD717301
• Catalog Number: HUD717301
• 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: true
• 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
• Phone: +1(800)633-5463
• Email: service@medline.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10197344007691 [Primary]
GS1	20197344007698 [Package]; Contains: 10197344007691; Package: CS [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220565

FDA Product Code

• BWF: SPIROMETER, THERAPEUTIC (INCENTIVE)

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: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [HUDSON RCI]

• 10197344007226: AQUAPAK LVN,STRL WATER,760ML,W/ 33 ADAPT
• 30197344010275: O2 CANNULA,PEDIATRIC,SOFTECH,7' TUB,SC
• 30193489149368: O2 CANN,ADULT,HI-FLO,EAR CUSH,7 TUB,SC
• 20193489149354: O2 CANNULA,ADULT,EAR CUSHION,7' TUB,SC
• 20197344010094: O2 CANNULA,INFANT,SOFTECH,7' TUB,SC
• 20197344009906: O2 CANNULA,ADULT,SOFTECH,25' TUB,UC
• 20197344009890: O2 CANNULA,ADULT,SOFTECH,50' TUB,UC
• 20197344009883: O2 CANNULA,PEDIATRIC,SOFTECH,7' TUB,UC
• 20193489149682: O2 CANNULA,ADULT,SOFTECH,14' TUB,UC
• 20193489149347: O2 CANNULA,ADULT,SOFTECH,7' TUB,SC GREEN
• 20193489149330: O2 CANNULA,PEDIATRIC,SOFTECH,14' TUB,SC
• 20193489149323: O2 CANNULA,PEDIATRIC,SOFTECH,NO TUBING
• 20193489149316: O2 CANNULA,ADULT,SOFTECH,4' TUB,SC
• 20193489149286: CANNULA,SOFTECH PLUS,PED,14 GRN STAR-LMN
• 20193489149279: O2 CANNULA,PEDI,SOFTECH +,7' TUB,UC
• 20193489149262: O2 CANNULA,ADULT,SOFTECH +,7' TUB,UC
• 10197344007202: AQUAPAK LVN,STRL WATER,440ML,W/ 28 ADAPT
• 10193489149241: O2 CANN,ADULT,HI-FLO,EAR CUSH,14 TUB,SC
• 20197344010285: O2 CANNULA,ADULT,SOFTECH,50' TUB,SC
• 20197344009951: O2 CANNULA,ADULT,SOFTECH,14' TUB,SC
• 20197344009937: O2 CANNULA,ADULT,SOFTECH,NO TUBING
• 20197344009913: O2 CANNULA,ADULT,SOFTECH,25' TUB,SC
• 20197344006028: AQUAPAK LVN,STRL WATER,1070ML,NO ADAPTER
• 20193489149699: O2 CANN,ADULT,SOFTECH,7' SMOOTH TUB,SC
• 20197344010216: O2 CANNULA,ADULT,SOFTECH +,7' TUB,SC
• 20197344010209: O2 CANNULA,PEDIATRIC,SOFTECH +,7' TUB,SC
• 20197344010193: O2 CANNULA,INFANT,SOFTECH +,7' TUB,SC
• 20197344010186: O2 CANNULA,NEONATAL,SOFTECH +,7' TUB,SC
• 20197344010179: O2 CANNULA,ADULT,SOFTECH +,14' TUB,SC
• 20197344007698: SPIROMETER,INCENTIVE,TRIFLO II,EXERCISER
• 20197344010933: TEMPERATURE PROBE, DISPOSABLE, NEPTUNE
• 30197344008128: ADDIPAK SALINE .45%, 3ML, STERILE
• 20193489149729: METER,PEAK FLOW,ASTHMAMD,60-810 LPM
• 20197344009968: O2 CANNULA,ADULT,SOFTECH,10' TUB,SC
• 20197344009944: O2 CANNULA,ADULT,SOFTECH,7' TUB,SC
• 20197344009920: O2 CANNULA,ADULT,SOFTECH,7' TUB,UC
• 20193489149712: ADAPTER,AEROSOL,NEB,22MM OD X 18MM OD
• 20193489149675: ADAPTR, VALVED TEE, 22MM OD/OD X 18MM
• 20193489149552: CANNULA, NASAL, INFANT, COMFORT FLO
• 10197344037384: NEBULIZER, TURBOMIST, MOUTHPC, 7' TUB SC
• 10197344037278: NEB, TRBMST, PED MSK, 7' TUB, SC, XADPT
• 20197344007476: AQUAPAK ADAPTER,ALARM,ADAPTER ONLY
• 20193489138471: AQUAKPAK BUBBLE HUM,540ML,NO ADAPTER
• 10197344037407: NEB, TURBOMIST, MOUTHPIECE
• 10197344037391: NEB, TURBOMIST, MTHPC, 7' TUB SC, XADPT
• 10197344037292: NEB, TURBOMIST, ADT MSK, LADT, 7' TUB SC
• 10197344037285: NEB, TURBOMIST, ADT MSK, LADT, 7' TUB UC
• 10197344037261: NEB, TURBOMIST, PED MSK, LADT, 7' TUB SC
• 10197344037193: NEB, TURBOMIST, PED MSK, LADT, 7' TUB UC
• 20197344077561: NEB, TURBOMIST, CUP ONLY