AccessGUDID - DEVICE: Molded Products, Inc. (B144UM872360)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: UM-872-36
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UM-872-36
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144UM872360
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: STERILE ACCESS & RETURN LINE SET

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?
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOC	Accessories, Blood Circuit, Hemodialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003712	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: ff84ce00-352c-4189-a6fd-4a445625d277
Public Version Date: June 07, 2019
Public Version Number: 4
DI Record Publish Date: September 07, 2016