FDA.reportPublic FDA data

Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs

Primary DI
M995979800183
Brand
Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs
Company
Delfi Medical Innovations Inc
Model
9-7980-018
Device description
Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff.
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M995979800183PackageHIBCC10In Commercial Distribution
M995979800181PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16047420600info@delfimedical.com

Regulatory Flags#

DUNS number
251078945
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M99597580024L1BFR Throwing Cuff, Reusable 9-7580-021L2026-01-14
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set 9-2200-250BFR2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable 9-7580-018L2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable 9-7580-018R2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable 9-7580-021R2026-01-14
M995979800181Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0182026-01-08
M995979800211Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0212026-01-08
M995979900181Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0182026-01-08
M995979900211Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0212026-01-08
M995996000421Adaptive Cylindrical Cuff, Limited Reuse 9-9600-0422026-01-08
M995979700181Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0182026-01-08
M995979700241Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0242026-01-08
M995979700301Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0302026-01-08
M995979700341Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0342026-01-08
M995979700421Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0422026-01-08
M995979800213Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0212026-01-08
M995979900183Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0182026-01-08
M995979900213Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0212026-01-08
M995995000181Adaptive Cylindrical Cuff, Limited Reuse 9-9500-0182026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse 9-9500-0242026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204011Compression StockingGottfried Medical, Inc.FQL2026-06-04