FDA.report

Halyard

Primary DI
30680651466410
Brand
Halyard
Company
Avanos Medical, Inc.
Model
46641
Catalog number
44-4100
Device description
FARRELL* Valve Closed Enteral Decompression System with ENFit® Connectors
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PIFGastrointestinal Tubes with Enteral Specific Connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651466410PackageGS130In Commercial Distribution
10680651466416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065146641030680651466410
1068065146641610680651466416

GMDN Terms

TermDefinition
Enteral feeding bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)425-9273xxx@xxx.xxx

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

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