FDA.reportPublic FDA data

Matching Limb Protection Sleeves for Adaptive Cuffs

Primary DI
M995979700421
Brand
Matching Limb Protection Sleeves for Adaptive Cuffs
Company
Delfi Medical Innovations Inc
Model
9-7970-042
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. (MLPS for Adaptive 42"" Limited Reuse, Easy-Tear)"
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M995979700423PackageHIBCC10In Commercial Distribution
M995979700421PrimaryHIBCC0

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
6047420600info@delfimedical.com

Regulatory Flags#

DUNS number
251078945
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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
M995979800183Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0182026-01-08
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
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° BlackSIGVARIS INCFQL2026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN BlackSIGVARIS INCFQL2026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° CaramelSIGVARIS INCFQL2026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN CaramelSIGVARIS INCFQL2026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° GreySIGVARIS INCFQL2026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN GreySIGVARIS INCFQL2026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° SavannaSIGVARIS INCFQL2026-07-22
07613378198861862P-CUSTOM ECF2 AT SoftTop MEN SavannaSIGVARIS INCFQL2026-07-22
07613378199257862P-CUSTOM ECF2 AT SoftTop MEN °° SkinSIGVARIS INCFQL2026-07-22
07613378199646862P-CUSTOM ECF2 AT SoftTop MEN SkinSIGVARIS INCFQL2026-07-22
07613378277542862P-CUSTOM ECF2 AT SoftTop MEN marineSIGVARIS INCFQL2026-07-22
07613378277931862P-CUSTOM ECF2 AT SoftTop MEN °° marineSIGVARIS INCFQL2026-07-22
07613378196133862P-CUSTOM ECF2 AT SoftTop MEN °° BlackSIGVARIS INCFQL2026-07-20
07613378196539862P-CUSTOM ECF2 AT SoftTop FEM BlackSIGVARIS INCFQL2026-07-20
07613378196928862P-CUSTOM ECF2 AT SoftTop FEM °° CaramelSIGVARIS INCFQL2026-07-20
07613378197314862P-CUSTOM ECF2 AT SoftTop FEM CaramelSIGVARIS INCFQL2026-07-20
07613378197703862P-CUSTOM ECF2 AT SoftTop FEM °° GreySIGVARIS INCFQL2026-07-20
07613378198090862P-CUSTOM ECF2 AT SoftTop FEM GreySIGVARIS INCFQL2026-07-20
07613378198489862P-CUSTOM ECF2 AT SoftTop FEM °° SavannaSIGVARIS INCFQL2026-07-20
07613378198878862P-CUSTOM ECF2 AT SoftTop FEM SavannaSIGVARIS INCFQL2026-07-20
07613378199264862P-CUSTOM ECF2 AT SoftTop FEM °° SkinSIGVARIS INCFQL2026-07-20
07613378199653862P-CUSTOM ECF2 AT SoftTop FEM SkinSIGVARIS INCFQL2026-07-20
07613378277535862P-CUSTOM ECF2 AT SoftTop FEM marineSIGVARIS INCFQL2026-07-20
07613378277924862P-CUSTOM ECF2 AT SoftTop FEM °° marineSIGVARIS INCFQL2026-07-20
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