FDA.reportPublic FDA data

N/A

Primary DI
00607411930393
Brand
N/A
Company
SALTER LABS
Model
LW-105
Catalog number
LW-105-0-25
Device description
Luma Wrap, extra large
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDHblanket, neonatal phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDHBlanket, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142416000Luma WrapSalter Labs2015-06-12PDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411930390PackageGS125In Commercial Distribution
00607411930393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741193039010607411930390
00607411930393006074119303936074119303930607411930393

GMDN Terms#

Term, Definition table
TermDefinition
Infant blanket, reusableA piece of fabric material intended to be used to wrap newborns/infants to retain their body heat. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a reusable device after appropriate cleaning.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411890178N/A891289122016-09-24
00607411890185N/A891389132016-09-24
00607411890246N/A892389232016-09-24
00607411000881N/A5006-15006-12016-09-24
00607411917332Salter LabsOTC-101-7 (QTY 5)OTC-101-7 (QTY 5)2026-10-07
00607411917363Salter LabsOTC-102-4 (QTY 5)OTC-102-4 (QTY 5)2026-10-07
00607411917394Salter LabsOTC-102-7 (QTY 5)OTC-102-7 (QTY 5)2026-10-07
00607411000966AirLife7001-07001-02016-11-30
00607411001130AirLife1220-01220-02016-11-30
00607411001215AirLife1225-01225-02016-11-30
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510PT3000ADVANCED PHOTOTHERAPY LAMP ADVANCED INSTRUMENTATIONS, INC.PDH2025-08-21
00859911004351BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004368BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004276Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00859911004283Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00607411930379N/ASALTER LABSPDH2017-01-30
00607411930386N/ASALTER LABSPDH2017-01-30
08599110040133BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040140BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040119BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040126BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25