FDA.reportPublic FDA data

Calibration Hose Set for PTS BFR, metal (PLC)

Primary DI
M995922006113
Brand
Calibration Hose Set for PTS BFR, metal (PLC)
Company
Delfi Medical Innovations Inc
Model
9-2200-611
Device description
Calibration Hose set for the use with PTS BFR Portable Tourniquet System.
Published
2023-05-25
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
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M995922006113PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Contacts#

Phone, Email table
PhoneEmail
16047420600info@delfimedical.com

Regulatory Flags#

DUNS number
251078945
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
M995979700421Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0422026-01-08
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
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