FDA.report

Devon

Primary DI
20192253042020
Brand
Devon
Company
Cardinal Health 200, LLC
Model
31142667
Catalog number
31142667
Device description
Devon Tube Holder Removable Touch Fasten Strap
Published
2025-03-07
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

Related Records

Product Codes

CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253042020PackageGS125In Commercial Distribution
50192253042021PackageGS14In Commercial Distribution
10192253042023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225304202020192253042020
5019225304202150192253042021
1019225304202310192253042023

GMDN Terms

TermDefinition
Medical/surgical interventional tube/cable securement strapA strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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