GIBECK 5385
GUDID 24026704734164
PEEP VALVE,DISPOSABLE
TELEFLEX INCORPORATED
PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use PEEP valve, single-use| Primary Device ID | 24026704734164 |
| NIH Device Record Key | cc47b540-a91e-44e0-9aa5-f91661c0b382 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GIBECK |
| Version Model Number | IPN924729 |
| Catalog Number | 5385 |
| Company DUNS | 002348191 |
| Company Name | TELEFLEX INCORPORATED |
| 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(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM |
Device Dimensions
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
| Length | 1.18 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean dry conditions away from heat and light. |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14026704734167 [Primary] |
| GS1 | 24026704734164 [Package] Contains: 14026704734167 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964719
FDA Product Code
| BTM | Ventilator, emergency, manual (resuscitator) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-12 |
| Device Publish Date | 2023-04-04 |
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 |
Trademark Results [GIBECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GIBECK 75131868 2245295 Live/Registered |
ICOR AKTIENBOLAG 1996-07-10 |
 GIBECK 74314961 2027331 Dead/Cancelled |
GIBECK, INC. 1992-09-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.