Primary Device ID | 00841277110159 |
NIH Device Record Key | 5b512b5b-f600-4d6f-a181-6dd02b0c307c |
Commercial Distribution Discontinuation | 2025-03-17 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Sempermed skySense |
Version Model Number | BBLN303 |
Catalog Number | BBLN303 |
Company DUNS | 004072158 |
Company Name | SEMPERMED USA, INC. |
Device Count | 300 |
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 | true |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com | |
Phone | 800-366-9545 |
Glove.Info@SempermedUSA.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841277110098 [Primary] |
GS1 | 00841277110159 [Unit of Use] |
OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-25 |
Device Publish Date | 2025-03-17 |
00841277110173 | Sempermed skySense, 300 Nitrile Exam Glove Powder Free- XL |
00841277110166 | Sempermed skySense, 300 Nitrile Exam Glove Powder Free- L |
00841277110159 | Sempermed skySense, 300 Nitrile Exam Glove Powder Free- M |
00841277110142 | Sempermed skySense, 300 Nitrile Exam Glove Powder Free- S |
00841277110135 | Sempermed skySense, 300 Nitrile Exam Glove Powder Free- XS |