SDR Vehicle Kit Refill-OTC - 31-115 TMT Tourniquet 1.00EAGLOVES-2.00.101 - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: 31-115 TMT Tourniquet 1.00EAGLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, 31-115 TMT Tourniquet 1.00EAGLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA11-100-QR-EN POSTIONAL AIRWAY - ENGLISH 2.00 1.00EAL-SDR-VSIP-OTC-REFILSDR Vehicle Kit - OTC-Refill Insert 1.00EA20-001-KOI Sentinel Chest Seal 2.00 1.00EAFCP-01 ETD 1.00EABPS-47 Blizzard IFAK 1.00EA95-000-QR-EN MARCH Cover QR Card - English 1.00EA31-115-QR-EN TMT - ENGLISH 1.00EA30-212-QR-EN CELOX RAPID B-CON - ENGLISH 1.00EA20-001-QR-EN SENTINEL CHEST SEAL - ENGLISH 1.00EA32-150-QR-EN COMPRESSION DRESSING - ENGLISH 1.00EA04-101-QR-EN EMERGENCY BLANKET - ENGLISH 1.00EAP81-111 Snap Ring, 1/2" ID, Acetal (.55/13.5mm ID) 1.00EAL01-00 33x1 blank polypropylene TT label 1.00EAP81-250-07 Inner Pouch, PA Kit 7x1 1.00EAP59-100 Inner Pouch, Hypothermia Kit 1.00EA

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More Product Details

Catalog Number

SDR-VSIP-OTC

Brand Name

SDR Vehicle Kit Refill-OTC

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 02, 9999

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OHO

Product Code Name

First Aid Kit Without Drug

Device Record Status

Public Device Record Key

fb32d032-2c88-4ade-95ef-d5a7b99fd25a

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48