AccessGUDID - DEVICE: Atellica CH PAmy (00630414595641)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH PAmy
Version or Model: 11097622
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11097622
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414595641
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Pancreatic Amylase (Pamy) Atellica CH - RGT 1720T

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?
59073	Amylase isoenzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an amylase isoenzyme in a clinical specimen, using a spectrophotometry method. This test is typically used to detect salivary or pancreatic alpha-amylase to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFJ	CATALYTIC METHODS, AMYLASE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971825	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64ad3949-b47a-4ed7-b0b7-f8deb60ee67a
Public Version Date: May 21, 2024
Public Version Number: 8
DI Record Publish Date: December 21, 2017