Blom

GUDID 00841470101183

PULMODYNE INC

Basic tracheostomy tube, single-use

• Primary Device ID: 00841470101183
• NIH Device Record Key: 6b0defb9-0839-44dd-9093-25176890efe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blom
• Version Model Number: 313-01-040
• Company DUNS: 030619483
• Company Name: PULMODYNE 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: 317-246-5505
• Email: infor@pulmodyne.com

Device Dimensions

• Outer Diameter: 9.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470101183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062104

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-06

On-Brand Devices [Blom]

• 10841470103344: 313-13-100
• 10841470103337: 313-13-080
• 10841470103320: 313-13-060
• 10841470103313: 313-13-040
• 10841470103306: 313-12-100
• 10841470103290: 313-12-080
• 10841470103283: 313-12-060
• 10841470103276: 313-12-040
• 10841470103269: 313-11-100
• 10841470103252: 313-11-080
• 10841470103245: 313-11-060
• 10841470103238: 313-11-040
• 10841470103221: 313-10-100
• 10841470103214: 313-14-100
• 10841470103207: 313-14-080
• 10841470103191: 313-10-080
• 10841470103184: 313-14-060
• 10841470103177: 313-14-040
• 10841470103160: 313-10-060
• 10841470103139: 313-10-040
• 00841470101213: 313-01-100
• 00841470101206: 313-01-080
• 00841470101190: 313-01-060
• 00841470101183: 313-01-040
• 00841470101176: 3113-00-100
• 00841470101169: 313-00-080
• 00841470101152: 313-00-060
• 00841470101145: 313-00-040
• 20841470100661: 313-71-015
• 20841470100654: 313-71-000
• 20841470100647: 313-70-000
• 20841470100630: 313-50-100
• 20841470100623: 313-50-080
• 20841470100616: 313-50-060
• 20841470100609: 313-50-040
• 10841470100596: 313-40-100
• 10841470100589: 313-40-080
• 10841470100572: 313-40-060
• 10841470100565: 313-40-040
• 10841470100558: 313-30-100
• 10841470100541: 313-30-080
• 10841470100534: 313-30-060
• 10841470100527: 313-30-040
• 20841470100517: 313-22-100
• 00841470100506: 313-22-080
• 20841470100494: 313-22-060
• 20841470100487: 313-22-040
• 00841470100476: 313-20-100
• 00841470100452: 313-20-080
• 20841470100432: 313-20-060