AccessGUDID - DEVICE: Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Black (00616784713526)

GUDID

Device Identifier (DI) Information

Brand Name: Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Black
Version or Model: 7135
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784713526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: Complete Kit Includes: 3 sets of eartips, Large & small diaphragm, Diaphragm removal tool, Adult, pediatric & infant bells, Dual tubing that transmits faint sounds.

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:	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?
13755	Mechanical external stethoscope	A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.	Active	false
32659	Foetal stethoscope	A mechanical listening device that is used for listening to foetal heart sounds. It is typically designed as a hollow tube (trumpet-shaped) to transmit the foetal heart sound through the inner channel by air conduction and is pressed against the outside of the mother's abdomen and the user will place their head and ear to the listening end of the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDE	Stethoscope, Manual

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: 2b2df4ea-5a58-4595-9eb9-72f9479b77ec
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: April 22, 2021