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
00607411946684Salter Labs47SOFT-TG-14-1447SOFT-TG-14-142026-08-03
00607411961342N/A4707TG-7-74707TG-7-72026-08-03
00607411400049N/A4002-7-74002-7-72016-09-24
00607411400056N/A4002F-7-74002F-7-72016-09-24
00607411400162N/A4101-7-74102-7-72016-09-24
00607411400940N/A4796F-7-04796F-7-02016-09-24
00607411400957N/A4797-7-74797-7-72016-09-24
00607411400964N/A4797F-7-74797F-7-72016-09-24
00607411401015N/A4793-7-74793-7-72016-09-24
00607411401039N/A4793F-7-74793F-7-72016-09-24
00607411801211N/A4102F-7-74102F-7-72016-09-24
00607411918421N/A4002-14-144002-14-142016-09-24
00607411947360N/A4797TG-7-74797TG-7-72017-10-26
00607411947124N/A49SOFT-TG-10-1049SOFT-TG-10-102026-07-28
00607411947131N/A49SOFT-TG-14-1449SOFT-TG-14-142026-07-28
00607411947162N/A49SOFT-F-14-1449SOFT-F-14-142026-07-28
00607411000263N/A4702F-7-04702F-7-02016-09-24
00607411000270N/A4703F-7-74703F-7-72016-09-24
00607411400391N/A4700-7-74700-7-72016-09-24
00607411400407N/A4700F-7-74700F-7-72016-09-24

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