FDA.reportPublic FDA data

Dale Transducer Holder

Primary DI
H84106201
Brand
Dale Transducer Holder
Company
Dale Medical Products, Inc.
Model
620
Catalog number
620
Device description
Dale Transducer Holder, Fits most
Published
2018-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817612020858PackageGS110In Commercial Distribution
H84106202PackageHIBCC10In Commercial Distribution
H84106201PreviousHIBCC0
00817612020841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612020858008176120208588176120208580817612020858
00817612020841008176120208418176120208410817612020841

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, single-useA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001061233
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021114Dale IV Line Manager6306302025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08