FDA.report

AVANOS

Primary DI
00350770428673
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
7140-12-3.5
Catalog number
7140-12-3.5
Device description
MIC-KEY* SF G Feeding Tubes with ENFit® Connectors
Published
2020-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00350770428673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770428673003507704286733507704286730350770428673

GMDN Terms

TermDefinition
Gastrostomy buttonA sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge12French

Sterilization Methods

Method

Contacts

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
true
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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