FDA.report

Ballard* Closed Suction System for Adults

Primary DI
00609038947150
Brand
Ballard* Closed Suction System for Adults
Company
Avanos Medical, Inc.
Model
94715
Catalog number
220123568
Device description
BALLARD* Closed Suction Catheter, T-Piece, WET PAK*
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20609038947154PackageGS12In Commercial Distribution
00609038947150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2060903894715420609038947154
00609038947150006090389471506090389471500609038947150

GMDN Terms

TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge14French

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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