FDA.reportPublic FDA data

AVANOS

Primary DI
10193494001336
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
CB004-PF
Catalog number
CB004-PF
Device description
CB004-PF ON-Q, CB004, 400 ML PF
Published
2021-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K063530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063530000ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPI-Flow Corp.2007-01-26MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193494001336PackageGS110In Commercial Distribution
00193494001339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349400133610193494001336
00193494001339001934940013391934940013390193494001339

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump systemAn assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014360644-242026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014370645-142026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1200014380645-202026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULL1200014390645-242026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095831020645-142026-10-14
00193493000753GenVisc 850 Sodium Hyaluronate50653-0006-0150653-0006-012024-03-06
00193493000760TriVisc Sodium Hyaluronate50653-0006-0450653-0006-042024-03-06
00850653006016GenVisc® 850 sodium hyaluronate50653-0006-012016-10-31
00850653006047TriVisc™ sodium hyaluronate50653-0006-042018-12-20
10680651467185Halyard46718N589132017-12-21
10680651467192Halyard46719N589072017-12-21

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Primary DI, Brand, Company table
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18859299175192SMARTeZ RSEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-09-04
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