Primary Device ID | H29740121 |
NIH Device Record Key | 3dcf4054-92e3-437e-849b-4ad6a460fbee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mini Tempheart |
Version Model Number | 4012 |
Catalog Number | 060985 |
Company DUNS | 029351079 |
Company Name | MEASUREMENT SPECIALTIES, INC. |
Device Count | 100 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 800-899-9783 |
medfeedback@te.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H29740120 [Unit of Use] |
HIBCC | H29740121 [Primary] |
KGX | Tape And Bandage, Adhesive |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-22 |
Device Publish Date | 2018-09-21 |
H29740091 - Tempheart | 2018-10-22 MEAS Tempheart® Shields |
H2974010 - Reusable GP Temperature Probe | 2018-10-22 Reusable Temperature Probe – Esophageal/Rectal (Adult) |
H29740100 - Extension Cable | 2018-10-22 10’ Extension Cable (400 Series) |
H29740121 - Mini Tempheart | 2018-10-22MEAS Mini-Tempheart® Shields |
H29740121 - Mini Tempheart | 2018-10-22 MEAS Mini-Tempheart® Shields |
H2974020 - Reusable GP Temperature Probe | 2018-10-22 Reusable Temperature Probe – Esophageal/Rectal (Pediatric) |
H2974030 - Reusable Tubular Temperature Probe | 2018-10-22 .157” dia. S. S. Tubular Reusable Temperature Probe |
H2974060 - Reusable Tubular Temperature Probe | 2018-10-22 .125” dia. S. S. Tubular Reusable Temperature Probe |
H297409A0 - Reusable Skin Temperature Probe | 2018-10-22 Reusable Temperature Probe – Skin (Adult) |