| Primary Device ID | 20813079022606 |
| NIH Device Record Key | 691ec14d-5703-44ee-9a30-f7993b530003 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Necessities Kit |
| Version Model Number | NK-01 |
| Catalog Number | NK-01 |
| Company DUNS | 788472314 |
| Company Name | REMINGTON MEDICAL, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com | |
| Phone | +1(800)989-0057 |
| Quality@Remmed.com |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813079022602 [Primary] |
| GS1 | 10813079022609 [Package] Contains: 00813079022602 Package: Inner Carton [10 Units] In Commercial Distribution |
| GS1 | 20813079022606 [Package] Contains: 10813079022609 Package: Shipping Carton [12 Units] In Commercial Distribution |
| OEQ | Angiography/angioplasty kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20813079022606]
Ethylene Oxide
[20813079022606]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-11 |
| Device Publish Date | 2018-11-10 |
| 10813079022616 - VascuChek Surgical Probe | 2024-09-02 Surgical Probe (sterile) used with transceiver |
| 00813079022626 - VascuChek Transceiver | 2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow. |
| 00813079022633 - VascuChek Charger | 2024-09-02 Replacement Charger used with the transceiver |
| 00813079022640 - VascuChek Kit | 2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel |
| 10813079022654 - VascuChek Clinical Probe | 2024-09-02 Clinical Probe (non-sterile) used with transceiver. |
| 10813079020223 - Bone Marrow "I" Needle | 2020-10-02 15ga (1.8mm) x 1 7/8" (5cm) |
| 20813079020237 - Bone Marrow "I" Needle | 2020-10-02 16ga (1.7mm) x 1 7/8" (5cm) |
| 10813079020247 - Bone Marrow "J" Needle Double Diamond Tip | 2020-10-02 11ga (3.0mm) x 4in. (10cm) |