FDA.reportPublic FDA data

Motion Medical Distributing

Primary DI
15061100781475
Brand
Motion Medical Distributing
Company
Haslam Medical, Inc.
Model
SO-100
Catalog number
SO-100
Device description
safeBVM Sotair device + Ambu BVM Manual Resuscitation Kit, Adult Use
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
15061100781475PackageGS16In Commercial Distribution
05061100781478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506110078147515061100781475
05061100781478050611007814785061100781478

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, reusableA 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 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002924056mhaslam@motionmedical.net

Regulatory Flags#

DUNS number
604208868
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
05061100781478Motion Medical DistributingSO-100SO-1002025-06-13
05061100781485Motion Medical DistributingSO-200SO-2002025-06-13
15061100781482Motion Medical DistributingSO-200SO-2002025-06-13
15060498452158Motion Medical Distributing187424352021-02-15
15060498452189Motion Medical Distributing2004PG2004PG2022-12-29
15060498452172Motion Medical Distributing164216422022-02-17
25060498452179Motion Medical Distributing164216422022-02-17
25060498452155Motion Medical Distributing187418742021-02-15
15060498452141Motion Medical Distributing157115712021-01-26
25060498452148Motion Medical Distributing157115712021-01-26
15060498452134Motion Medical Distributing157315732021-01-04
25060498452131Motion Medical Distributing157315732021-01-04
15060498452097Motion Medical Distributing183118312020-12-04
15060498452103Motion Medical Distributing183318332020-12-04
15060498452110Motion Medical Distributing180918092020-12-04
15060498452127Motion Medical Distributing183918392020-12-04
25060498452094Motion Medical Distributing183118312020-12-04
25060498452100Motion Medical Distributing183318332020-12-04
25060498452117Motion Medical Distributing180918092020-12-04
25060498452124Motion Medical Distributing183918392020-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344097401MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
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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
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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