AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC2601)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-260
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-260
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC2601
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Rivetless Fistula Pressure Clamp, White

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:	No
Prescription Use (Rx):	No
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?
46604	Vascular puncture haemostasis arm clamp/band, reusable	A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site in a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXD	Clamp

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f49407ad-b0a8-4178-a382-e46247b219c2
Public Version Date: August 09, 2024
Public Version Number: 1
DI Record Publish Date: August 01, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B144MPC2602	30	B144MPC2601		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: B144MPC2600 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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