FDA.reportPublic FDA data

Koala Toco®

Primary DI
20814247020288
Brand
Koala Toco®
Company
CLINICAL INNOVATIONS, LLC
Model
KDT-1000
Device description
Koala Toco® Single-Use Tocodyamometer
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HFMMonitor, Uterine Contraction, External (For Use In Clinic)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140163000KOALA TOCOClinical Innovations, LLC2014-05-29HFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247020281PackageGS110In Commercial Distribution
20814247020288PackageGS14In Commercial Distribution
00814247020284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702028110814247020281
2081424702028820814247020288
00814247020284008142470202848142470202840814247020284

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocograph transducerA device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals. It is a dedicated transducer (a tocodynamometer) that is usually strapped onto the womans abdomen. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809524291
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00814247021304Panniculus Retraction KitPRS-CK-05SM2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallPRS-CK-05MD2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
20884838059324Avalon Fetal & Maternal PatchPhilips Medical Systems HsgHFM2020-05-25
00884838068179Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbHHFM2020-05-22
00840682142571TOCO TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2018-11-01
00884838034235Avalon CL Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-19
00884838002715Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
00884838021471Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
M745FM10839AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10840AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10841AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
00814247020284Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
B249VA000380FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA000381FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001060FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001061FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002020FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002030FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002190FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002191FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003100FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003101FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003110FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003111FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003120FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003121FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
00840682104111N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2016-06-24