FDA.reportPublic FDA data

Ventlab

Primary DI
20889483082482
Brand
Ventlab
Company
VENTLAB, LLC
Model
BVM800
Device description
PEDIATRIC VINYL BAG
Published
2016-12-22
Public version status
Update
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
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483082482PackageGS110In Commercial Distribution
10889483082485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948308248220889483082482
1088948308248510889483082485

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify0036086

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038305402
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
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
10889483227046VentlabR500P21R500P212023-07-18
10889483227022VentlabR500P30R500P302023-07-17
10889483228364VentlabR500P31R500P312023-07-17
10889483228371VentlabR500P32R500P322023-07-17
10889483100745VentlabHS4251-D22016-12-22
10889483096925VentlabVR2700-20VR2700-202023-06-02
10889483098585VentlabVR2400-40VR2400-402023-06-02
10889483099094VentlabVR4700-20VR4700-202023-06-02
10889483104132VentlabVR2400-100VR2400-1002023-06-02
10889483107287VentlabVR1100-40VR1100-402023-06-02
10889483111529VentlabVR5700-20VR5700-202023-06-02
10889483112175VentlabVR2100-40VR2100-402023-06-02
10889483112298VentlabVR3700-20VR3700-202023-06-02
10889483160831VentlabVR1900-20VR1900-202023-06-02
10889483160855VentlabVR2900-20VR2900-202023-06-02
10889483160879VentlabVR3900-20VR3900-202023-06-02
10889483160930VentlabVR5900-20VR5900-202023-06-02
10889483164273VentlabVR4500-20VR4500-202023-06-02
10889483164297VentlabVR5500-20VR5500-202023-06-02
10889483164334VentlabVR7500-20VR7500-202023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344097395MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097401MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097418MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097425MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097432MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097449MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100446MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100453MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100477MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100484MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344110902MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100460MEDLINEMEDLINE INDUSTRIES, INC.BTM2024-12-05
10195327558598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTM2023-12-21
10193489139303MedlineMEDLINE INDUSTRIES, INC.BTM2023-02-04
10193489189162MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489189179MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489181937MedlineMEDLINE INDUSTRIES, INC.BTM2022-11-10
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489003123MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-22
10193489092400MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-12
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001952MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489009767MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003116MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003758MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10190752141308AirLife™AIRLIFEBTM2021-05-03
10190752141315AirLife™AIRLIFEBTM2021-05-03
10190752141346AirLife™AIRLIFEBTM2021-05-03