BiTrac
GUDID 10841470106369
PULMODYNE INC
CPAP/BPAP face mask, single-use| Primary Device ID | 10841470106369 |
| NIH Device Record Key | 75e5b20b-4c8a-4446-87d1-f8157e40ca23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiTrac |
| Version Model Number | 313-9001W |
| Company DUNS | 030619483 |
| Company Name | PULMODYNE INC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 317-246-5505 |
| info@engmedsys.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470106362 [Primary] |
| GS1 | 10841470106369 [Package] Contains: 00841470106362 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023683
FDA Product Code
| BZD | Ventilator, Non-Continuous (Respirator) |
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 | 2018-07-06 |
| Device Publish Date | 2016-09-30 |
On-Brand Devices [BiTrac]
| 10841470108165 | 313-9075 |
| 10841470108158 | 313-9074 |
| 10841470108134 | 313-9076 |
| 00841470108120 | 313-9073 |
| 00841470108113 | 313-9072 |
| 00841470108106 | 313-9071 |
| 10841470108097 | 313-9070 |
| 10841470109421 | 313-9085 |
| 10841470107977 | 313-9616 |
| 10841470107960 | 313-9615 |
| 10841470107946 | 313-9614 |
| 10841470107939 | 313-9613 |
| 10841470107168 | 313-9008 |
| 10841470107151 | 313-9007 |
| 10841470107144 | 313-9006 |
| 10841470107120 | 313-9005 |
| 10841470107007 | 313-9015W |
| 10841470106468 | 313-9016W |
| 10841470106451 | 313-9014W |
| 10841470106444 | 313-9013W |
| 10841470106390 | 313-9004W |
| 10841470106383 | 313-9003W |
| 10841470106376 | 313-9002W |
| 10841470106369 | 313-9001W |
Trademark Results [BiTrac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BITRAC 90533714 not registered Live/Pending |
Engineered Medical Systems, Inc. 2021-02-18 |
 BITRAC 73374651 1241949 Dead/Cancelled |
Transducer Systems, Inc. 1982-07-14 |
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