AccessGUDID - DEVICE: Capillaries pH/Blood Gas/Na+/K+ (00630414099231)

GUDID

Device Identifier (DI) Information

Brand Name: Capillaries pH/Blood Gas/Na+/K+
Version or Model: 10310990
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 471836
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414099231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: 100 blood collection capillary tubes (approx. volume 100uL) Each tube contains 130-200 I.U./mL lithium heparin titrated with Na+/K+. For capillary blood collection for the analysis of pH/Blood Gas and Na+/K+ by ISE analyzer

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?
61388	Capillary blood collection tube IVD, lithium heparin	A non-sterile glass or plastic collection tube containing the anticoagulant lithium heparin, 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
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: Avoid direct 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: 6e69c359-d7ad-4028-88a2-4e475f9a3795
Public Version Date: January 19, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016