GIBECK 28052

GUDID 44026704389061

ISO GARD HEPA SMALL A

TELEFLEX INCORPORATED

Microbial medical gas filter, single-use

• Primary Device ID: 44026704389061
• NIH Device Record Key: 78e18716-03de-4330-962d-ed08b573d20c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIBECK
• Version Model Number: IPN044101
• Catalog Number: 28052
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: true
• 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(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026704389063 [Primary]
GS1	24026704389067 [Package]; Contains: 04026704389063; Package: Box [25 Units]; In Commercial Distribution
GS1	44026704389061 [Package]; Contains: 24026704389067; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954828

FDA Product Code

• CAH: Filter, bacterial, breathing-circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-09-16

On-Brand Devices [GIBECK]

• 44026704389061: ISO GARD HEPA SMALL A
• 24026704348125: ISO GARD HEPA SMALL S
• 24026704348095: ISO GARD HEPA LIGHT
• 24026704348088: ISO GARD HEPA LIGHT
• 44026704348075: ISO GARD HEPA LIGHT PORT
• 24026704348002: ISO GARD FILTER S
• 24026704717730: HUMID-VENT FILTER COMPACT S
• 24026704400816: HUMID-VENT HEPA, TETHERED CAP
• 44026704400797: HUMID-VENT HEPA
• 24026704388749: HUMID VENT FILTER LIGHT S
• 24026704388312: HUMID VENT FILTER LIGHT A
• 44026704348662: HUMID VENT FILTER SMALL S
• 44026704348648: HUMID VENT FILTER SMALL A
• 24026704348026: HUMID-VENT FILTER COMPACT S
• 44026704347962: HUMID VENT FILTER COMPACT A
• 44026704347849: HUMID VENT FILTER PEDI
• 34026704744436: SOFTFLEX® Tube
• 34026704734185: HUMID-VENT®, Compact, Straight w/ SOFTFLEX
• 24026704734164: PEEP VALVE,DISPOSABLE
• 24026704734157: DISPOSABLE PEEP VALVE W/22MM OD CONNECT.
• 34026704744498: Softech Bi-Flo Cannula
• 34026704744481: Softech Bi-Flo Cannula
• 34026704744474: Softech Bi-Flo Cannula
• 34026704744467: Softech Bi-Flo Cannula
• 34026704744450: Softech Bi-Flo Cannula
• 34026704744443: Softech Bi-Flo Cannula
• 24026704917024: SOFTECH® Plus ETCO2 Cannula
• 24026704917017: SOFTECH® Plus ETCO2 Cannula
• 24026704917000: SOFTECH® Plus ETCO2 Cannula
• 24026704916980: SOFTECH® Plus ETCO2 Cannula
• 24026704916973: SOFTECH® Plus ETCO2 Cannula