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(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves

FDA UDI

Class II (US FDA UDI)

by Rondex Products, Incorporated

Identity

Trade Name
(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves FDA UDI
Generic Name
Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for keying pocket cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA. FDA UDI
Model / Reference
Model #9850-G FDA UDI
Description
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for keying pocket cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA. FDA UDI

Identifiers

Catalog Number
MKRS9850G FDA UDI
Primary DI / UDI-DI
00634376498576 FDA UDI
510(k) Number
K981169 FDA UDI
FDA Product Code
CBP FDA UDI
GMDN Term
Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use

(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves by Rondex Products, Incorporated — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Cardiopulmonary resuscitation mask, single-use.

Cleared under the same submission

K981169 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rondex Products, Incorporated

Sources (1)

  • FDA UDI 6a38ee2a-0fbe-4ea6-8577-9d67f34f2d39 36 fields · synced Jun 8, 2026