AccessGUDID - DEVICE: IMMULITE® 1000 Systems1000 Sample Cup Caps (00630414974194)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 1000 Systems1000 Sample Cup Caps
Version or Model: 10385183
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LSCC
Company Name: SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

Primary DI Number: 00630414974194
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 186812384 *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:	Yes
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?
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2da39061-57f1-44e2-9f5b-695678ae14ef
Public Version Date: October 31, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2020