FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00810019800016
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
123627
Catalog number
123627A
Device description
Blanket, Baby
Published
2019-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNCTable, Obstetric (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNCTable, Obstetric (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932035000NON-LINTING DELIVERY BLANKETAmsco Sterile Recoveries, Inc.1994-05-26KNC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019800016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019800016008100198000168100198000160810019800016

GMDN Terms#

Term, Definition table
TermDefinition
Infant blanket, single-useA piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Weight0.3Pound
Width8Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019800627NOVO Health Services, LLC1262681262682020-03-10
00812564030528NOVO Health Services, LLC120307120307B2018-09-24
00812564030634NOVO Health Services, LLC120424120424B2018-09-24
00812564030894NOVO Health Services, LLC120621120621D2018-09-24
00812564031914NOVO Health Services, LLC121168121168B2018-09-24
00812564032102NOVO Health Services, LLC121311121311G2018-09-24
00812564032300NOVO Health Services, LLC121705121705E2018-09-24
00812564033635NOVO Health Services, LLC124175124175B2018-09-24
00812564033741NOVO Health Services, LLC124255124255B2018-09-24
00812564033949NOVO Health Services, LLC124512124512C2018-09-24
00812564033956NOVO Health Services, LLC124513124513C2018-09-24
00812564033963NOVO Health Services, LLC124514124514C2018-09-24
00812564033970NOVO Health Services, LLC124515124515C2018-09-24
00812564033987NOVO Health Services, LLC124516124516F2018-09-24
00812564034380NOVO Health Services, LLC124922124922D2018-09-24
00812564034625NOVO Health Services, LLC1260611260612018-09-24
00812564034830NOVO Health Services, LLC126267126267B2018-09-24
00812564034977NOVO Health Services, LLC63206320D2018-10-01
00812564035066NOVO Health Services, LLC1273361273362018-09-24
00812564035103NOVO Health Services, LLC1273641273642018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761978164COMFORT PAD ASSEMBLYHILL-ROM, INC.KNC2020-07-15
00810019800405NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2020-01-30
00812564037244NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564037282NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564037312NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564037442NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2019-05-09
00812564035592NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564036513NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564039378NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00812564039651NOVO Health Services, LLCNOVO HEALTH SERVICES, LLCKNC2018-09-24
00887761000896Affinity® 4 Birthing BedHILL-ROM, INC.KNC2016-09-17
00887761995451Leg SupportHILL-ROM, INC.KNC2016-09-17
00887761995468Leg SupportHILL-ROM, INC.KNC2016-09-17
00887761995475Calf SupportHILL-ROM, INC.KNC2016-09-17
00887761995482Calf SupportHILL-ROM, INC.KNC2016-09-17
00887761995574Extension PadHILL-ROM, INC.KNC2016-09-17
00887761998346Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998353Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998360Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998377Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998384Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998391Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998407Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998414Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998421Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998438Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998445Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998452Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998469Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17
00887761998476Affinity® SurfaceHILL-ROM, INC.KNC2016-09-17