FDA.reportPublic FDA data

Koala®

Primary DI
00814247020154
Brand
Koala®
Company
CLINICAL INNOVATIONS, LLC
Model
IPC-5000C
Device description
Koala® Intrauterine Pressure Catheter with internal balloon
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HFNTransducer, Pressure, Intrauterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFNTransducer, Pressure, IntrauterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974389000KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.1998-02-19HFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814247020151PackageGS110In Commercial Distribution
20814247020158PackageGS15In Commercial Distribution
00814247020154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081424702015110814247020151
2081424702015820814247020158
00814247020154008142470201548142470201540814247020154

GMDN Terms#

Term, Definition table
TermDefinition
Intrapartum pressure monitoring catheterA flexible tube with a pressure sensor, transducer, and/or thermistor located at its distal tip, used for intrapartum transcervical measurement of the intrauterine and amniotic pressures. It is attached at its proximal end via a signal cable to an external monitor that displays the pressure/temperature values, and is used to monitor the intensity, duration, and frequency of uterine contractions during labour. It may also be used for fluid infusion and sampling of amniotic fluid. It is typically made of plastic [e.g., polyethylene, polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane] and/or silicone, and may include a catheter introducer/sheath. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809524291
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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 GmbHHFN2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HFN2020-04-16
00884838001404NAPhilips Medizin Systeme Böblingen GmbHHFN2016-11-21
H671IUP4000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
00814247020178Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
20814247020172Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020192Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020208Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020215Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020222Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020239Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01