FDA.report

Medline

Primary DI
40888277355287
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
5921218236R
Catalog number
5921218236R
Device description
5921-218-236 COLOR TRNQT,RED
Published
2022-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KCYTOURNIQUET, PNEUMATIC

Product Code Classifications

CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40888277355287PackageGS110In Commercial Distribution
10888277355286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088827735528740888277355287
1088827735528610888277355286

GMDN Terms

TermDefinition
Tourniquet cuff, reprocessedA sterile, band-like device intended to be applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or following serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff may comprise a dual-chamber allowing alternation of the pressure site to avoid tissue damage or necrosis. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set Delfi Medical Innovations IncKCY2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M995995000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000421Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
08809802646971DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646988DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646995DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
M99592500002BFR1PTS for BFR Generation 3 - Dual Channel SystemDelfi Medical Innovations IncKCY2025-06-17
16976514770009Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770016Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770023Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770030Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770047Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770054Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770061Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770078Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770085Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770092Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770108Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770115Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770122Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23