Captian Eagle Pediatric Nebulizer

GUDID 00372217005056

Captian Eagle Pediatric Nebulizer

ARISE MEDICAL LLC

Nebulizing system delivery set, reusable
Primary Device ID00372217005056
NIH Device Record Key8b491135-b55d-437c-944d-b712333d0593
Commercial Distribution StatusIn Commercial Distribution
Brand NameCaptian Eagle Pediatric Nebulizer
Version Model Number240487
Company DUNS081149273
Company NameARISE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100372217005056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-10
Device Publish Date2019-05-02

Devices Manufactured by ARISE MEDICAL LLC

00372217036081 - Safecare Vinyl Exam Gloves2023-02-16 Safecare Vinyl Exam Gloves - M- 100 Ct
00372217036098 - Safecare Vinyl Exam Gloves2023-02-16 Safecare Vinyl Exam Gloves - L- 100 Ct
00372217036104 - Safecare Vinyl Exam Gloves2023-02-16 Safecare Vinyl Exam Gloves - XL- 100 Ct
00372217036319 - Safecare Vinyl Exam Gloves2023-02-16 Safecare Vinyl Exam Gloves - XS- 100 Ct
00372217036326 - Safecare Vinyl Exam Gloves2023-02-16 Safecare Vinyl Exam Gloves - S- 100 Ct
00372217004035 - Procare Basic Upper Arm BP Monitor2020-08-31 Upparm Arm blood pressure monitor with standard cuff
00372217004042 - Procare Upper Arm BP Monitor with XL Cuff2020-08-31 Procare Upper Arm BP Monitor with XL Cuff
00372217005094 - Safari Express Pediatric Nebulizer2020-08-31 Safari Express Pediatric Nebulizer

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.