ProTrach® DualCare™ Set 22
GUDID 07331791008184
ProTrach DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. I
Atos Medical AB
Tracheostomy tube speech valve| Primary Device ID | 07331791008184 |
| NIH Device Record Key | 67c7e020-f7dc-4fbe-8b1e-5397f3081bca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProTrach® DualCare™ Set 22 |
| Version Model Number | 7740 |
| Company DUNS | 355470923 |
| Company Name | Atos Medical AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com | |
| Phone | +4641519800 |
| info@atosmedical.com |
Device Dimensions
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331791008184 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151404
FDA Product Code
| JOH | Tube Tracheostomy And Tube Cuff |
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 | 2018-08-23 |
| Device Publish Date | 2016-09-27 |
Devices Manufactured by Atos Medical AB
| 07331791017209 - Provox Life Home HME Experience | 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791017216 - Provox Life Go HME Experience | 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791014901 - Freevent XtraCare Mini White | 2023-12-12 Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter in |
| 07331791008023 - Provox StabiliBase (3pcs) | 2023-11-03 The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. T |
| 07331791009044 - Provox StabiliBase OptiDerm (3pcs) | 2023-11-03 Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheosto |
| 07331791010293 - Provox XtraBase (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791010309 - Provox FlexiDerm Round (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791010316 - Provox FlexiDerm Oval (3pcs) | 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
Trademark Results [ProTrach]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROTRACH 79147632 4741296 Live/Registered |
Atos Medical AB 2013-10-17 |
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