NAMIC DYNJINFLATEPO

GUDID 20197344104939

INFLATION,DEVICE,20ML,30ATM

MEDLINE INDUSTRIES, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 20197344104939
• NIH Device Record Key: d5e6517f-154a-4ecf-908d-39c1d021eb68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAMIC
• Version Model Number: DYNJINFLATEPO
• Catalog Number: DYNJINFLATEPO
• 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: false
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10197344104932 [Primary]
GS1	20197344104939 [Package]; Contains: 10197344104932; Package: CS [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170027

FDA Product Code

• MAV: Syringe, balloon inflation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-17
• Device Publish Date: 2024-09-09

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• 10193489079029: MTO COMP MP 3V 200S RH OFF BARD PG
• 10193489079012: COMP MP 3V 200S RH ON BARD PG
• 10193489079005: MTO PERC MP 3V 200S RH OFF BARD PG
• 10193489078992: PERC MP 3V 200S RH ON BARD PG
• 10193489077834: FITTING,MLL 24609203 - OEM
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• 10193489068177: CIL HP 60 FLL-RA-OEM
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• 10193489068078: WMMII MP 4V 200S RH STR OFF OEM
• 10193489068061: WMMII MP 3V 200S RH STR ON OEM
• 10193489068054: WMMII MP 3V 200S RH STR OFF OEM
• 10193489068047: WMMII 2V 200S RH STR ON OEM
• 10193489068030: WMMII 2V 200S RH STR OFF OEM
• 10193489068023: MTO LABEL COLOR CODE/3000 BAG/OEM
• 10193489068016: CABLE, 12 REUS NO ADAP 3001-0295
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• 10193489067910: CIL FLEX 30 FLL-RA - OEM
• 10193489067903: MTO CIL FLEX 30 MLL-FLL - OEM
• 10193489067897: CIL 20 FLEXCIL F-RA - OEM
• 10193489067880: MTO CIL FLEX 20 FLL-MLL - OEM
• 10193489067873: CIL FLEX 10 FLL-RA - OEM
• 10193489067866: MTO CIL FLEX 10 FLL-MLL - OEM
• 10193489067859: MTO CIL FLEX 4 MLL-FLL - OEM
• 10193489067842: CIL CLEARA 48 FLL-RA - OEM
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• 10193489067828: CIL CLEARA 30" FLL-RA - OEM
• 10193489067811: CIL CLEARA 30" FLL-MLL - OEM
• 10193489067804: CIL CLEARA 20" FLL-RA - OEM
• 10193489067798: CIL CLEARA 20" FLL-MLL - OEM - PG
• 10193489067781: CIL CLEARA 10" FLL-RA - OEM
• 10193489067774: CIL CLEARA 10" FLL-MLL - OEM
• 10193489067767: CIL LP 48 FLL-MLL - OEM
• 10193489067750: CIL LP 30 FLL-MLL - OEM
• 10193489067743: CIL LP 20 FLL-MLL - OEM