AccessGUDID - DEVICE: DCA® Systems Microalbumin/Creatinine Capillary holders and plungers (00630414027364)

GUDID

Device Identifier (DI) Information

Brand Name: DCA® Systems Microalbumin/Creatinine Capillary holders and plungers
Version or Model: 10888739
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10888739
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414027364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.

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?
35770	Capillary blood collection tube IVD, no additive	A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963142	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64fe0088-bbef-4ebe-bf7c-563b11a48af0
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: March 01, 2017