FDA.reportPublic FDA data

Emergency Response Kit

Primary DI
00883873772676
Brand
Emergency Response Kit
Company
PHYSIO-CONTROL, INC.
Model
11998
Catalog number
11998-000334
Device description
Emergency Response Kit
Published
2023-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXDPrep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXDPrep KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873772676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873772676008838737726768838737726760883873772676

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
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-1142rs.seacustomersupport@stryker.com

Regulatory Flags#

DUNS number
009251992
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883873031902LIFEPAK 35 Monitor/Defibrillator7033570335-0002242026-04-17
00883873031933LIFEPAK 35 Monitor/Defibrillator7033570335-0002262026-04-17
00883873031957LIFEPAK 35 Monitor/Defibrillator7033570335-0002272026-04-17
00883873031971LIFEPAK 35 Monitor/Defibrillator7033570335-0002282026-04-17
00883873031995LIFEPAK 35 Monitor/Defibrillator7033570335-0002292026-04-17
00883873032015LIFEPAK 35 Monitor/Defibrillator7033570335-0002302026-04-17
00883873032145LIFEPAK 35 Monitor/Defibrillator7033570335-0002312026-04-17
00883873030608LIFEPAK 15 AC Power Adapter4157741577-0003332026-02-10
07613327666656LIFEPAK 15 AC Power Adapter1114011140-0000982025-02-07
07613327673197LIFEPAK 35 Monitor/Defibrillator9933599335-000013U2025-12-18
07613327673227LIFEPAK 35 Monitor/Defibrillator9933599335-000029U2025-12-18
07613327673234LIFEPAK 35 Monitor/Defibrillator9933599335-000030U2025-12-18
07613327673241LIFEPAK 35 Monitor/Defibrillator9933599335-000033U2025-12-18
07613327673258LIFEPAK 35 Monitor/Defibrillator9933599335-000034U2025-12-18
07613327673265LIFEPAK 35 Monitor/Defibrillator9933599335-000031U2025-12-18
07613327673357LIFEPAK 35 Monitor/Defibrillator9933599335-000032U2025-12-18
07613327681864LIFEPAK 35 Monitor/Defibrillator9933599335-000028U2025-12-18
07613327691344LIFEPAK 35 Monitor/Defibrillator9633596335-000000U2025-12-18
07613327691351LIFEPAK 35 Monitor/Defibrillator9633596335-000001U2025-12-18
00883873760031BATTERY, LI-ION, LP351114111141-0001742025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840365903055InvenioGri-Alleset, Inc.PXD2025-03-12
10840365903052InvenioGRI Medical & Electronic Technology Co., Ltd.PXD2025-03-12
10304040167721Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
10304040167943Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167724Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167946Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
M752UPC502L0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502L5Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M5Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
H65857008711Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008721Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008731Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008741Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008751Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008761Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008715Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008725Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008735Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008745Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008755Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008765Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09