FDA UDI In Commercial Distribution 🇺🇸 United States

Capillaries pH/Blood Gas/Na+/K+

DI: 00630414099231 · Model: 10310990 · Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

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Basic Information

Brand Name
Capillaries pH/Blood Gas/Na+/K+
Primary DI
00630414099231
Version / Model
10310990
Catalog Number
471836
Company Name
Siemens Healthcare Diagnostics Inc.
Labeler DUNS
064608573
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2016-09-24
Public Version
5
Public Version Date
2022-01-19
Public Version Status
Update
Public Device Record Key
6e69c359-d7ad-4028-88a2-4e475f9a3795

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

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GIO TUBE, COLLECTION, CAPILLARY BLOOD

GMDN Terms

Code Name
61388 Capillary blood collection tube IVD, lithium heparin

Identifiers

Type ID
Primary 00630414099231
Unit of Use 00630414009247

Customer Contacts

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Avoid direct sunlight
Type
Storage Environment Temperature
Temperature Range
4 – 25 Degrees Celsius