DONALDSON VENT TUBE

GUDID 00844505002660

DONALDSON VENT TUBE W/TAB 1.14MM ID SILICONE 5 PACK

Grace Medical, Inc.

Tympanostomy tube

• Primary Device ID: 00844505002660
• NIH Device Record Key: 4eb9be1f-d128-4efc-ab89-c3c178d359aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DONALDSON VENT TUBE
• Version Model Number: 510-001
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505002660 [Primary]
GS1	10844505002667 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981575

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-18
• Device Publish Date: 2016-02-18

On-Brand Devices [DONALDSON VENT TUBE]

• 00844505008440: DONALDSON VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC PAIR 10 PACK
• 00844505008433: DONALDSON VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 00844505007719: DONALDSON VENT TUBE 1.14MM ID - SILICONE PAIR 60 PACK
• 00844505007696: DONALDSON VENT TUBE 1.14MM ID - SILICONE 50 PACK
• 00844505007672: DONALDSON VENT TUBE 1.14MM ID PC SILICONE 5 PACK
• 00844505007665: DONALDSON VENT TUBE W/TAB 1.14MM ID - SILICONE 30 PACK
• 00844505003735: DONALDSON VENT TUBE 1.14MM ID FLUOROPLASTIC PAIR 10 PACK
• 00844505003728: DONALDSON VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
• 00844505002707: DONALDSON VENT TUBE 1.14MM ID SILICONE PAIR 10 PACK
• 00844505002691: DONALDSON VENT TUBE 1.14MM ID SILICONE 5 PACK
• 00844505002684: DONALDSON VENT TUBE W/TAB 1.14MM ID SILICONE PAIR 10 PACK
• 00844505002677: DONALDSON VENT TUBE W/ TAB 1.14MM ID PC SILICONE 5 PACK
• 00844505002660: DONALDSON VENT TUBE W/TAB 1.14MM ID SILICONE 5 PACK