FDA.reportPublic FDA data

NA

Primary DI
07613327169331
Brand
NA
Company
STRYKER CORPORATION
Model
DBK9
Catalog number
DBK9
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100585000MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900Gaymar Industries, Inc.2011-01-20DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327169331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327169331076133271693317613327169331

GMDN Terms#

Term, Definition table
TermDefinition
External cuff/pad connection tubingA length of flexible tube intended to be used to deliver air and/or fluid from a pump to a noninvasive, patient-contact pad, pack or cuff. It may be intended for use with a specific type of assembly (e.g., circulating-air/fluid thermal therapy system, electronic sphygmomanometer, venous compression system). It is typically made of synthetic material and may be intended to be permanently attached to the system control unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30