FDA.report

Peritoneal Dialysis

Primary DI
00884450277478
Brand
Peritoneal Dialysis
Company
Merit Medical Systems, Inc.
Model
00884450277478
Published
2016-09-16
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

Product Codes

CodeName
FKXSYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Product Code Classifications

CodeDeviceSpecialtyClass
FKXSystem, Peritoneal, Automatic DeliveryGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K823296000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K823296000PC-205 TENCKHOFF CATHETER ROD OBTURATORMedigroup1983-01-26FKX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884450277478PrimaryGS10

GMDN Terms

TermDefinition
Peritoneal catheter styletA sterile thin wire/rod intended to be inserted within the lumen of a percutaneous peritoneal catheter (i.e., peritoneal dialysis catheter, peritoneal drainage catheter) to stiffen/maintain the shape of the catheter to assist introduction. It is intended to be removed once the catheter is in place. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
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