AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC725D1)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-725D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-725D
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC725D1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: In-Series Tandem Dialysate Line - White, Disposable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58093	Haemodialysis treatment kit	A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform a haemodialysis treatment with a haemodialysis system. It typically consists of tubing, haemodialysis dialysers, dialysate concentrates, and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FID	Tubing, Dialysate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022068	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d31f3922-dace-404c-8b65-8603184d98af
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: B144MPC725D0 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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