FDA.reportPublic FDA data

Vital Signs™

Primary DI
30889483600966
Brand
Vital Signs™
Company
AIRLIFE
Model
IN800012
Catalog number
IN800012
Device description
Vital Signs™ Pressure Infusor
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483600966PackageGS112In Commercial Distribution
10190752133723PreviousGS10
10889483600962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360096630889483600966
1019075213372310190752133723
1088948360096210889483600962

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, manual, reusableA manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933705BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933712BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933729BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933736BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933743BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933750BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933767BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933774BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00810132043789HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043796HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043680HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043697HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043703HCSConcordance Healthcare Solutions LLCKZD2025-10-23
10889483600962Vital Signs™AIRLIFEKZD2025-07-31
10889483600986Vital Signs™AIRLIFEKZD2025-07-31
10889483600993Vital Signs™AIRLIFEKZD2025-07-31
10889483601013Vital Signs™AIRLIFEKZD2025-07-31
10889483601037Vital Signs™AIRLIFEKZD2025-07-31
10889483642368Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642382Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642405Vital Signs™SUNMED, LLCKZD2025-07-31
00816317024277Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
00811220035488PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
00811220035501PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
10889483230770InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10889483230787InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10193489033106MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10193489033113MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10197344020508MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21
00816317022372Vital SignsRENU MEDICAL, INCKZD2023-06-27