FDA.reportPublic FDA data

Birthing Sling Manual

Primary DI
05056387405148
Brand
Birthing Sling Manual
Company
SILVALEA LIMITED
Model
BIRTH1
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056387405148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056387405148050563874051485056387405148

GMDN Terms#

Term, Definition table
TermDefinition
Manual patient lifting belt/harnessA device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
423632996
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056387401836Silvalea Boned Back Stand aid poly loops LARGE202GL2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUM202GM2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGE202GXL2025-03-13
05056387439426Rachel Harness Mesh Navy XXXSmallM921535-XXXS2024-08-05
05056387439433Rachel Harness Mesh Navy XXSmallM921535-XXS2024-08-05
05056387439440Rachel Harness Mesh Navy Extra SmallM921535-XS2024-08-05
05056387439457Rachel Harness Mesh Navy SmallM921535-S2024-08-05
05056387439464Rachel Harness Mesh Navy MediumM921535-M2024-08-05
05056387439471Rachel Harness Mesh Navy LargeM921535-L2024-08-05
05056387439488Rachel Harness Mesh Navy Extra LargeM921535-XL2024-08-05
05056387439495In-Situ Deluxe Superfine Double Layer XXXSmallM921536-XXXS2024-08-05
05056387439501In-Situ Deluxe Superfine Double Layer XXSmallM921536-XXS2024-08-05
05056387439518In-Situ Deluxe Superfine Double Layer Extra SmallM921536-XS2024-08-05
05056387439525In-Situ Deluxe Superfine Double Layer SmallM921536-S2024-08-05
05056387439532In-Situ Deluxe Superfine Double Layer MediumM921536-M2024-08-05
05056387439549In-Situ Deluxe Superfine Double Layer LargeM921536-L2024-08-05
05056387439556In-Situ Deluxe Superfine Double Layer Extra LargeM921536-XL2024-08-05
05056387439563Tinkham Sling Superfine Plus XXSmallM921537-XXS2024-08-05
05056387439570Tinkham Sling Superfine Plus Extra SmallM921537-XS2024-08-05
05056387439587Tinkham Sling Superfine Plus SmallM921537-S2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810045517582HandicareHANDICARE USA, INC.INE2025-08-13
00810045517599HandicareHANDICARE USA, INC.INE2025-08-13
00810045517605HandicareHANDICARE USA, INC.INE2025-08-13
00810045517575HandicareHANDICARE USA, INC.INE2025-05-09
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGESILVALEA LIMITEDINE2025-03-13
00810045517537HandicareHANDICARE USA, INC.INE2024-10-11
00810045517544HandicareHANDICARE USA, INC.INE2024-10-11
00810045517551HandicareHANDICARE USA, INC.INE2024-10-11
00810045517568HandicareHANDICARE USA, INC.INE2024-10-11
00810045517490HandicareHANDICARE USA, INC.INE2024-10-11
00810045517506HandicareHANDICARE USA, INC.INE2024-10-11
00810045517513HandicareHANDICARE USA, INC.INE2024-10-11
00810045517520HandicareHANDICARE USA, INC.INE2024-10-11
00810045517483HandicareHANDICARE USA, INC.INE2024-09-24
07898493080073Skin Cooler Roller - LARGE (white)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080080Skin Cooler Roller - LARGE (lilac)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080097Skin Cooler Roller - LARGE (blue)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080103Skin Cooler Roller - LARGE (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080141Skin Cooler Roller - SMALL (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
05060405746144BananaGBUK LTDINE2024-01-22
05060405746151BananaGBUK LTDINE2024-01-22
05060405746168BananaGBUK LTDINE2024-01-22
05060405746175BananaGBUK LTDINE2024-01-22
05060405746182BananaGBUK LTDINE2024-01-22
05060405746199BananaGBUK LTDINE2024-01-22
05060405746205BananaGBUK LTDINE2024-01-22
05060405746212BananaGBUK LTDINE2024-01-22
05060405746229BananaGBUK LTDINE2024-01-22