AccessGUDID - DEVICE: SA-3000P (00191237000014)

GUDID

Device Identifier (DI) Information

Brand Name: SA-3000P
Version or Model: SA-3000P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA-3000P
Company Name: Medicore Co., Ltd.

Primary DI Number: 00191237000014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688247753 *Terms of Use

Device Description: No description.

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?
13671	Sphygmograph	A device that functions as a graphic printer of the waveform of the arterial pulse. This instrument usually includes a lever, the short end of which rests on the radial artery at the wrist, its long end being provided with a stylet which records (usually on a moving paper) the excursions of the pulse. The waveform typically consists of a curve having a sudden rise, followed by a sudden fall, after which there is a gradual descend marked by a number of secondary elevations. This GMDN code may reflect old technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073323	000

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3be4ad50-16ea-48c1-a9da-e9d0fb126b11
Public Version Date: April 18, 2019
Public Version Number: 1
DI Record Publish Date: April 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10191237000011	1	00191237000014		In Commercial Distribution	Carton

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +82220562650
Email: bkyoo@medi-core.com

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