FDA.reportPublic FDA data

Patient Controlled Epidural Analgesia Device (PCEA)

Primary DI
09350902000310
Brand
Patient Controlled Epidural Analgesia Device (PCEA)
Company
GO MEDICAL INDUSTRIES PTY. LTD.
Model
PCEA
Catalog number
PCIEPRE15
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEBPump, Infusion, Elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972158000GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESPrinceton Regulatory Assoc.1998-02-20MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350902000327PackageGS15In Commercial Distribution
09350902000334PackageGS130In Commercial Distribution
09350902000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350902000327093509020003279350902000327
09350902000334093509020003349350902000334
09350902000310093509020003109350902000310

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory non-insulin infusion pump, mechanical, single-useA portable, non-electric, mechanically-powered device designed to be operated by healthcare professionals for dispensing a single dose of fluid medication [e.g., for antibiotic therapy, chemotherapy, patient-controlled analgesia (PCA)]. It consists of an empty reservoir intended to be filled with medication, a flow-rate regulator and a non-sterile (sterilizable) administration line intended to be connected to an infusion catheter (not included) for intravenous (IV), subcutaneous, intramuscular, or epidural administration. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a single-use device.

Regulatory Flags#

DUNS number
757634266
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350902000396Flow Control TubingFCT 10mL/5minFCT10-5m2016-09-24
09350902000426Flow Control TubingFCT 10mL/15minFCT10-15m2016-09-24
09350902000457Flow Control TubingFCT 10mL/30minFCT10-30m2016-09-24
09350902000488Flow Control TubingFCT 10mL/60minFCT10-60m2016-09-24
09350902000518Flow Control TubingFCT 10mL/2hFCT10-2h2016-09-24
09350902000549Flow Control TubingFCT 10mL/4hFCT10-4h2016-09-24
09350902000570Flow Control TubingFCT 10mL/6hFCT10-6h2016-09-24
09350902000600Flow Control TubingFCT 10mL/8hFCT10-8h2016-09-24
09350902000631Flow Control TubingFCT 10mL/12hFCT10-12h2016-09-24
09350902000662Flow Control TubingFCT 10mL/24hFCT10-24h2016-09-24
09350902000693Flow Control TubingFCT 10mL/48hFCT10-48h2016-09-24
09350902000723Flow Control TubingFCT 10mL/72hFCT10-72h2016-09-24
09350902000754Flow Control TubingFCT 30mL/5minFCT30-5m2017-05-16
09350902000785Flow Control TubingFCT 30mL/15minFCT30-15m2017-05-16
09350902000815Flow Control TubingFCT 30mL/30minFCT30-30m2017-05-16
09350902000846Flow Control TubingFCT 30mL/60minFCT30-60m2017-05-16
09350902000877Flow Control TubingFCT 30mL/2hFCT30-2h2017-05-16
09350902000907Flow Control TubingFCT 30mL/4hFCT30-4h2017-05-16
09350902000938Flow Control TubingFCT 30mL/6hFCT30-6h2017-05-16
09350902000969Flow Control TubingFCT 30mL/8hFCT30-8h2017-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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