THRESHOLD HS735EU-001
GUDID 00383730001043
Threshold PEP (735 EU) Single Unit.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Mechanical positive pressure airway secretion-clearing device| Primary Device ID | 00383730001043 |
| NIH Device Record Key | 0b2d6be4-549d-42c3-b4bc-5cfa3e8c686e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THRESHOLD |
| Version Model Number | 00 |
| Catalog Number | HS735EU-001 |
| Company DUNS | 220018415 |
| Company Name | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383730001043 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K961077
FDA Product Code
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-08-24 |
On-Brand Devices [THRESHOLD]
| 00383730001043 | Threshold PEP (735 EU) Single Unit. |
| 00383730001036 | Threshold PEP (735), 10 pack. |
| 00383730001029 | Threshold IMT (730EU) Single Unit. |
| 00383730001012 | Threshold IMT (730), 10 pack. |
| 00383730000138 | Threshold Pep Assembly |
| 00383730000121 | Threshold IMT Assesmbly |
Trademark Results [THRESHOLD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THRESHOLD 98468506 not registered Live/Pending |
Threshold Care, Inc. 2024-03-26 |
 THRESHOLD 97906376 not registered Live/Pending |
Threshold Rising, LLC 2023-04-25 |
 THRESHOLD 97906365 not registered Live/Pending |
Threshold Rising, LLC 2023-04-25 |
 THRESHOLD 97510531 not registered Live/Pending |
Kingspan Insulation LLC 2022-07-19 |
 THRESHOLD 97396217 not registered Live/Pending |
Pa, GuangFu 2022-05-05 |
 THRESHOLD 97369674 not registered Live/Pending |
Auricle Productions 2022-04-19 |
 THRESHOLD 88857853 not registered Live/Pending |
Vino Vida Wines, LLC 2020-04-02 |
 THRESHOLD 88701943 not registered Live/Pending |
TONINA MUSIC INC. 2019-11-21 |
 THRESHOLD 88317809 5942027 Live/Registered |
Data Management, Incorporated 2019-02-27 |
 THRESHOLD 88099965 not registered Live/Pending |
Threshold Shows, PBC 2018-08-30 |
 THRESHOLD 88059091 not registered Live/Pending |
Greatbatch Ltd. 2018-07-31 |
 THRESHOLD 87490843 not registered Dead/Abandoned |
Modne, Inc. 2017-06-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.