FDA.reportPublic FDA data

HeartStart

Primary DI
00884838055728
Brand
HeartStart
Company
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Model
FR3 Fast Response Kit
Catalog number
989803150111
Device description
Fast Response Kit, FR3
Published
2023-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838055728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838055728008848380557288848380557280884838055728

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, single-useA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079503890
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838055681HeartStartFR3 Infant Child Key9898031500312014-09-24
00884838055704HeartStartFR3 System Case, Ridge9898031499712014-09-24
00884838049987PHILIPS HeartStart FR3HeartStart FR38613882014-09-24
00884838049994PHILIPS HeartStart FR3HeartStart FR38613892014-09-24
10884838002842HeartStart Adult/Child Plus PadsHeartstart PadsM3713A2022-01-06
10884838002859HeartStartHeartstart PadsM3716A2022-02-25
10884838022048Adult/Child Pre-Connect Defib PadHeartstart Pads9898031660212022-01-06
00884838111486HeartStartHeartstart PadsM3716A2022-04-08
00884838023727PHILIPS FR/FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582212019-05-03
00884838023703PHILIPS HeartStart SMARTPADS IIFRx Smart Pads II9898031392612014-09-24
00884838023710FR2/FR2+ Adult Electrode PadsDP Electrode Pads9898031582112014-09-24
00884838023741PHILIPS HeartStart Adult SMART PadsHeartstart Adult Smart Pads CartridgeM5071A2014-09-24
00884838023765PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499812014-09-24
00884838023772PHILIPS HeartStart SMARTPADS IIISmart Pads III9898031499912014-09-24
00884838029569PHILIPS FR/FR2/FR2+ Adult Electrode Pads9898031582219898031582212014-09-24
00884838127784PHILIPS HeartStart Infant/Child SMART PadsHeartstart Infant Child Smart Pads Cart.M5072A2025-04-29
00884838023758PHILIPS HeartStart Infant/Child SMART PadsHeartstart Infant Child Smart Pads Cart.M5072A2014-09-24
00884838038004HeartStartFRx Infant Child Key9898031393112014-09-24
00884838048607HeartStartFR3 FAA Compliant Battery9898031501712018-04-20
00884838035096HeartStartFR3 Secondary Rechargeable Battery9898031502412018-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277227450 RV2 MASKHANS RUDOLPH, INC.KGB2025-10-16
07045432118124Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118223Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119145Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118131Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432119183Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119206Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119220Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119152Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119169Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119176Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119190Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119213Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119237Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119855Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29