Primary Device ID | M7831196481 |
NIH Device Record Key | a9e64cda-170b-4d63-9309-7f116ec20de1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CareGuard® |
Version Model Number | 1196-48 |
Catalog Number | 1196-48 |
Company DUNS | 030650113 |
Company Name | DIVERSATEK HEALTHCARE, INC. |
Device Count | 1 |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 800-558-6408 |
sales@diversatekhc.com |
Lumen/Inner Diameter | 16 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M7831196480 [Primary] |
HIBCC | M7831196481 [Package] Contains: M7831196480 Package: Case [100 Units] In Commercial Distribution |
MNK | Endoscopic Bite Block |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-10 |
Device Publish Date | 2016-09-17 |
M783119860XL1 | Bite Block With White Soft Strap |
M7831198601 | Bite Block With White Soft Strap |
M7831198481 | Bite Block With White Soft Strap |
M783119760XL1 | Bite Block |
M7831197600 | Bite Block |
M7831197481 | Bite Block |
M783119660XL1 | Bite Block with Blue Latex Free Strap |
M7831196600 | Bite Block with Blue Latex Free Strap |
M7831196481 | 1196-48 |