FDA UDI In Commercial Distribution 🇺🇸 United States

Slope Gas

DI: 00630414112978 · Model: 10311038 · Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Slope Gas
Primary DI
00630414112978
Version / Model
10311038
Catalog Number
477438000
Company Name
Siemens Healthcare Diagnostics Inc.
Labeler DUNS
064608573
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2021-11-19
Public Version Status
Update
Public Device Record Key
42ab71c5-fc07-4ffc-ba9e-9f9f11d863f4

Device Description

Slope Gas for in vitro use on Siemens Healthcare Diagnostics Blood Gas analyzers and systems

Device Characteristics

Single Use
No
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
BXX CALIBRATOR, PRESSURE, GAS

GMDN Terms

Code Name
35933 Multiple blood gas analyte IVD, calibrator

Identifiers

Type ID
Primary 00630414112978

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
18 – 25 Degrees Celsius