Aquilo Sports AQU655 AT2

GUDID 00850009827272

Aquilo Sports L.L.C.

External cuff/pad inflation tubing set, reusable
Primary Device ID00850009827272
NIH Device Record Keyef116474-ba6a-4562-9b60-f45adbbfce58
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquilo Sports
Version Model NumberAir Tube - Dual
Catalog NumberAQU655 AT2
Company DUNS080077503
Company NameAquilo Sports L.L.C.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850009827272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

On-Brand Devices [Aquilo Sports]

00850009827333CCT1500 System
00850009827319CT1000 System
00850009827562Air Tube - Single
00850009827463Knee Wrap - Right
00850009827456Ankle Wrap - Right
00850009827432Ankle Wrap - Left
00850009827425Knee Wrap - Left
00850009827395Full Leg Sleeve (L) - Right
00850009827388Full Leg Sleeve (L) - Left
00850009827357Full Leg Sleeve (M) - Left
00850009827340Full Leg Sleeve (M) - Right
00850009827272Air Tube - Dual

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.