FDA.reportPublic FDA data

Rescuer Disposable Resuscitation Cushion Mask (#0 Neonate)

Primary DI
B00215250
Brand
Rescuer Disposable Resuscitation Cushion Mask (#0 Neonate)
Company
B.L.S. Systems Limited
Model
1525
Catalog number
1525
Device description
Rescuer Disposable Resuscitation Cushion Mask (#0 Neonate)
Published
2018-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00215259PackageHIBCC40In Commercial Distribution
B00215250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resuscitator face mask, single-useA non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
9053391069tedreesor@blssystemsltd.com

Regulatory Flags#

DUNS number
200103823
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0026300Rescuer63002025-11-24
B00263050Rescuer630563052025-11-24
B0024050RB0Rescuer4050-RB4050-RB2024-06-12
B0024050RB7Rescuer4050-RB4050-RB2024-06-12
B0024000F0Rescuer4000F4000F2021-01-08
B0027000AD0Rescuer 7000-AD Replacement Suction Canister kit7000-AD7000-AD2018-10-02
B0027000MVP0Rescuer MVP Manual Vacuum Pump7000-MVP7000-MVP2018-10-02
B0023000X0Rescuer3000-X3000-X2023-12-11
B0023000X7Rescuer3000-X3000-X2023-12-11
B0028705NK0Rescuer Emergency CPAP with Medium CPAP Mask8705-NK8705-NK2020-01-06
B0024000UF0Rescuer Manual Resuscitator4000-U-F4000-U-F2021-04-20
B0024010UF0Rescuer Manual Resuscitator4010-U-F4010-U-F2021-04-20
B0024025UF0Rescuer Manual Resuscitator 4025-U-F4025-U-F2021-04-20
B0024050UF0Rescuer Manual Resuscitator4050-U-F4050-U-F2021-04-20
B0026205U0Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U0Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026200U0Rescuer O-Mask6200-U6200-U2021-04-01
B0026205U7Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)6205-U6205-U2021-04-01
B0026210U7Rescuer O-Mask Oxygen Mask with Universal Tubing6210-U6210-U2021-04-01
B0026100U0Rescuer Flo2Max Oxygen Mask, Large Adult61006100-U2020-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
10197344131662MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131693MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131723MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10612479274218McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274232McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274256McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274270McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274294McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10197344131679MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131686MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131709MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131716MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344103706MEDLINEMEDLINE INDUSTRIES, INC.BSJ2024-06-10
10193489135367MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135374MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135381MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10197344097180MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097197MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097203MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097210MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097227MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097234MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23