DEVICE: RNK Products (00067799300216)

Device Identifier (DI) Information

RNK Products
PCP-1
In Commercial Distribution

RNK PRODUCTS, INC.
00067799300216
GS1

1
010630522 *Terms of Use
PCP-1 Chest Piece
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electronic stethoscope An external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It will typically be connected to a computer so that the results can be presented on a screen.
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FDA Product Code

[?]
Product Code Product Code Name
DQD Stethoscope, Electronic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102893 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

33a8b8a5-8bfc-4ca9-83d0-cb27d3be816b
July 06, 2018
3
August 31, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
321.610.3980
abbruscato@rnkproducts.com
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