PAVmed™ Inflation Device 96519

GUDID 00856877002711

Inflation Device Atrion Part Number 96519: 40mL, 15atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00856877002711
• NIH Device Record Key: a35142f4-9d8f-470e-ac96-a401f6f62239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAVmed™ Inflation Device
• Version Model Number: QL4015
• Catalog Number: 96519
• Company DUNS: 047571476
• Company Name: ATRION MEDICAL PRODUCTS, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com
• Phone: +1(800)343-9334
• Email: info@atrionmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856877002711 [Primary]

FDA Product Code

• KOE: Dilator, Urethral
• PTM: Syringe, Balloon Inflation, Exempt

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: 2021-12-07
• Device Publish Date: 2021-11-29

Devices Manufactured by ATRION MEDICAL PRODUCTS, INC.

• 00856877002728 - QL Disposable Inflation Device: 2022-11-15 Inflation Device: 40mL, 15atm
• 00856877002711 - PAVmed™ Inflation Device: 2021-12-07Inflation Device Atrion Part Number 96519: 40mL, 15atm
• 00856877002711 - PAVmed™ Inflation Device: 2021-12-07 Inflation Device Atrion Part Number 96519: 40mL, 15atm
• 00856877002667 - QL Locking Syringe Device: 2021-07-01 Locking Syringe Device Atrion Part Number 96503: 38mL
• 00856877002650 - QL Disposable Inflation Device: 2021-02-04 Inflation Device Atrion Part Number 96515: 20mL, 30atm
• 00856877002445 - Boston Scientific Encore 40 Inflation Device: 2020-07-31 Inflation Device: 25mL, 40atm
• 00856877002636 - SIS MEDICAL 40atm Inflation Device: 2020-05-18 Inflation Device: 25mL, 40atm
• 00856877002643 - SIS MEDICAL 55atm Inflation Device: 2020-05-18 Inflation Device: 14mL, 55atm
• H965459830 - angiodynamics NAMIC™ Disposable Inflation Device: 2020-05-06 Inflation Device: 20mL, 30atm