ProTrach® HME 15 Regular
GUDID 07331791008207
The ProTrach HME 15 XtraMoist offers high humidification while the ProTrach HME 15/22 Regular offers a higher airflow.
Atos Medical AB
Tracheostomy tube speech valve| Primary Device ID | 07331791008207 |
| NIH Device Record Key | d4327fa1-a571-4fe4-9a25-91f12edb8459 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProTrach® HME 15 Regular |
| Version Model Number | 7742 |
| Company DUNS | 355470923 |
| Company Name | Atos Medical AB |
| Device Count | 30 |
| DM Exempt | false |
| 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 | 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 | |
| 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 | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
Operating and Storage Conditions
| 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. |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07331791008207 [Primary] |
| GS1 | 07331791010637 [Unit of Use] |
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
| 07331791016905 - Provox Adhesive OptiDerm Round | 2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016929 - Provox XtraBase Adhesive | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016899 - Provox Adhesive FlexiDerm Plus | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016912 - Provox Adhesive OptiDerm Plus | 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices |
| 07331791016943 - Provox Life Go HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016950 - Provox Life Home HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016967 - Provox Life Energy HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
| 07331791016974 - Provox Life Protect HME | 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma. |
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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