Primary Device ID | 10386040005395 |
NIH Device Record Key | 96409c59-7236-42e1-82d1-6e1eff410ac7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EXAMIX™ |
Version Model Number | 137232 |
Catalog Number | 137232 |
Company DUNS | 005473608 |
Company Name | Gc America Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10386040005395 [Primary] |
ELW | MATERIAL, IMPRESSION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-15 |
Device Publish Date | 2022-07-07 |
10386040005579 | EXAMIX™ NDS Monophase (purple) 32-Packs (32 x 48mL cartridges) |
10386040005449 | EXAMIX™ NDS Heavy (yellow) 80-Packs (80 x 48mL cartridges) |
10386040005432 | EXAMIX™ NDS Monophase (purple) 80-Packs (80 x 48mL cartridges) |
10386040005425 | EXAMIX™ NDS Regular (blue) 80-Packs (80 x 48mL cartridges) |
10386040005418 | EXAMIX™ NDS Injection (copper) 80-Packs (80 x 48mL cartridges) |
10386040005395 | EXAMIX™ NDS Heavy (yellow) 32-Packs (32 x 48mL cartridges) |
20386040005378 | EXAMIX™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips) |
10386040005340 | EXAMIX™ NDS Injection (copper) 32-Packs (32 x 48mL cartridges) |
20386040005316 | EXAMIX™ NDS Injection (copper) Two Packs (2 x 48mL cartridges, 6 x mixing tips) |
10386040005296 | EXAMIX™ NDS Monophase (purple) Value Packs (8 x 48mL cartridges, 24 x mixing tips) |
10386040005289 | EXAMIX™ NDS Regular (blue) Value Packs (8 x 48mL cartridges, 24 x mixing tips) |
10386040005272 | EXAMIX™ NDS Injection (copper) Value Packs (8 x 48mL cartridges, 24 x mixing tips) |
10386040005265 | EXAMIX™ NDS Heavy (yellow) Value Packs (8 x 48mL cartridges, 24 x mixing tips) |
10386040005227 | EXAMIX™ NDS Regular (blue) 32-Packs (32 x 48mL cartridges) |
20386040005200 | EXAMIX™ NDS Regular (blue) Two Packs (2 x 48mL cartridges, 6 x mixing tips) |
20386040000663 | EXAMIX™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXAMIX 78667162 3109281 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 2005-07-11 |