FDA.reportPublic FDA data

NA

Primary DI
00883873836330
Brand
NA
Company
PHYSIO-CONTROL, INC.
Model
21300
Catalog number
21300-008159
Device description
NIBP - TUBING, 6FT, BAYONET, UDI
Published
2018-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSKCOMPUTER, BLOOD-PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142430000LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014-12-19MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873836330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873836330008838738363308838738363300883873836330

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Feet

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
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

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