FDA.reportPublic FDA data

Halyard

Primary DI
20680651372219
Brand
Halyard
Company
O&M HALYARD, INC.
Model
37221
Catalog number
37221
Device description
Beginnings* Fetal Monitor Security Strap with Buttonhole Attachment
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISRBAND OR BELT, PELVIC SUPPORT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651372216PackageGS12In Commercial Distribution
20680651372219PrimaryGS10
90680651372218Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065137221630680651372216
2068065137221920680651372219
9068065137221890680651372218

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
25
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17
30680651496974Halyard49697496972025-05-17
30680651496981Halyard49698496982025-05-17
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776107104Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107111Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107128Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107135Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107142Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107159Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107166Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107173Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107180Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107197Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107203Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107210Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107227Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107234Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776107241Neotech CareNEOTECH CARE INC.ISR2026-07-23
00843776102239Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102246Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102253Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102260Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102277Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102819Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102826Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102833Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102840Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102857Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102864Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102871Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102888Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102956Neotech CareNEOTECH CARE INC.ISR2026-07-22
00843776102963Neotech CareNEOTECH CARE INC.ISR2026-07-22