AccessGUDID - DEVICE: MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb (00630414108476)

GUDID

Device Identifier (DI) Information

Brand Name: MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Version or Model: 10325868
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 473763
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414108476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDLyte Multicap blood collection capillary tubes (50 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.

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?
61419	Capillary blood collection tube IVD, electrolyte-balanced heparin	A non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). 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
GIO	TUBE, COLLECTION, CAPILLARY BLOOD

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40af01a1-8e80-4306-a44a-7953aa5433c7
Public Version Date: January 19, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016