AccessGUDID - DEVICE: Molded Products, Inc (B144MPC100S0)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc
Version or Model: MPC-100-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-100-S
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC100S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Latex-Free Access Site with Luer Slip

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":	Yes
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?
61141	Luer-formatted disinfection cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925927	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: 10d96ecc-a706-4fec-8418-d274a159aed9
Public Version Date: October 12, 2022
Public Version Number: 1
DI Record Publish Date: October 04, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B144MPC100S1	100	B144MPC100S0	In Commercial Distribution	Bag
B144MPC100S2	2	B144MPC100S1	In Commercial Distribution	Box
B144MPC100S3	25	B144MPC100S2	In Commercial Distribution	Case