FDA.report

Res-Cue Key Face Shield

Primary DI
05707480031399
Brand
Res-Cue Key Face Shield
Company
Ambu A/S
Model
248201102
Catalog number
248201102
Device description
ResCue Key w/ambu logo- black
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480018185PackageGS14In Commercial Distribution
05707480031399PackageGS125In Commercial Distribution
05707480034352PackageGS110In Commercial Distribution
05707480134847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480018185057074800181855707480018185
05707480031399057074800313995707480031399
05707480034352057074800343525707480034352
05707480134847057074801348475707480134847

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

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