FDA.reportPublic FDA data

N/A

Primary DI
00889024380738
Brand
N/A
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
60-7075-005-00
Catalog number
60-7075-005-00
Device description
ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF, SINGLE PORT, SINGLE BLADDER, 30 IN. (76 CM)
Published
2021-11-02
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

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
00889024380738PackageGS15In Commercial Distribution
00889024382619PackageGS12In Commercial Distribution
00889024377264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024380738008890243807388890243807380889024380738
00889024382619008890243826198890243826190889024382619
00889024377264008890243772648890243772640889024377264

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is 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 serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
137354267
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
true
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
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16