Primary Device ID | 50015482980080 |
NIH Device Record Key | 47058831-170f-41eb-b678-244a03e98604 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Assure® Lance |
Version Model Number | 980028 |
Company DUNS | 008171162 |
Company Name | ARKRAY USA, INC. |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 | false |
OTC Over-The-Counter | true |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx | |
Phone | 1-800-818-8877 |
xxx@xxx.xxx |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Needle Gauge | 28 Gauge |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00015482980085 [Primary] |
GS1 | 50015482980080 [Unit of Use] |
FMK | Lancet, Blood |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-06 |
Device Publish Date | 2020-03-27 |
50015482234237 - TechLITE PLUS PEN NEEDLES | 2024-03-19 Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. |
10015482880160 - TechLITE® Lancets, 26g | 2023-10-05 TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling. |
00015482880187 - TechLITE® Lancets, 28g | 2023-09-27 TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling. |
10015482232297 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482234321 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482235311 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482236325 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482238312 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |