FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216120037
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
1038SM-ASP
Device description
"BAND, FETAL MONITORING BELLY, SMALL/MEDIUM, HORIZONTAL STRETCH 12"" TO 24"", ABDOMINAL CIRCUMFERENCE 30"" TO 48"", BLUE WAISTBAND COLOR, NYLON/ 1EA/PK, 50PK/CS"
Published
2022-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840216120037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216120037008402161200378402161200370840216120037

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216127869Northside HospitalNSAMK-052026-07-23
00840216129290Quest DiagnosticsQD11X16KPAP2026-07-17
00840216129801LabCorpLC13X22BIO2026-07-17
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09

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