FDA.reportPublic FDA data

Halyard

Primary DI
30680651372506
Brand
Halyard
Company
O&M HALYARD, INC.
Model
37250
Catalog number
37250
Device description
Beginnings* Fetal Monitor Security Strap with VELCRO® Attachment
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
30680651372506PackageGS12In Commercial Distribution
20680651372509PrimaryGS10
90680651372508Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065137250630680651372506
2068065137250920680651372509
9068065137250890680651372508

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA patient-worn, 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, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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