Adaptive Cylindrical Cuff, Limited Reuse

GUDID M995995000421

Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper fit, and color coded for size identification. Each Delfi Adaptive Tourniquet Cuff includes a single use Matching Limb Protection Sleeve. Delfi Adaptive Tourniquet Cuffs are provided sterile, and may be reused in a non-sterile manner for up to five uses. Delfi Adaptive Tourniquet Cuffs are not designed to be resterilized. Dispose of properly after use.

Delfi Medical Innovations Inc

Tourniquet cuff, single-use
Primary Device IDM995995000421
NIH Device Record Keyc96201b5-b6b7-4a5b-ab03-72a6b29f625f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdaptive Cylindrical Cuff, Limited Reuse
Version Model Number9-9500-042
Company DUNS251078945
Company NameDelfi Medical Innovations Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM995995000421 [Primary]
HIBCCM995995000423 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-16
Device Publish Date2026-01-08

On-Brand Devices [Adaptive Cylindrical Cuff, Limited Reuse ]

M995996000341Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995996000301Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995996000241Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995996000181Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995995000421Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995995000341Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995995000301Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995995000241Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f
M995995000181Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper f

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.