BABYPAC
Ventilator, Emergency, Powered (resuscitator)
SMITHS MEDICAL INTERNATIONAL LTD., LUTON
The following data is part of a premarket notification filed by Smiths Medical International Ltd., Luton with the FDA for Babypac.
Pre-market Notification Details
| Device ID | K043495 |
| 510k Number | K043495 |
| Device Name: | BABYPAC |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | SMITHS MEDICAL INTERNATIONAL LTD., LUTON N7 W22025 JOHNSON DRIVE Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander SMITHS MEDICAL INTERNATIONAL LTD., LUTON N7 W22025 JOHNSON DRIVE Waukesha, WI 53186 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-04-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315071892 | K043495 | 000 |
| 15019517181173 | K043495 | 000 |
| 10610586045547 | K043495 | 000 |
| 10610586045523 | K043495 | 000 |
| 35019517159664 | K043495 | 000 |
| 10610586045653 | K043495 | 000 |
Trademark Results [BABYPAC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BABYPAC 90244639 not registered Live/Pending |
LAR Digital Logistics 2020-10-09 |
 BABYPAC 75074325 not registered Dead/Abandoned |
Advantex Marketing International Inc. 1996-03-18 |
 BABYPAC 74272975 not registered Dead/Abandoned |
ADVANTEX MARKETING INTERNATIONAL INC. 1992-05-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.