FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216120051
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
1038XL-ASP
Device description
BAND, FETAL MONITORING BELLY, XLARGE, HORIZONTAL STRETCH 16" TO 32", ABDOMINAL CIRCUMFERENCE 38" TO 64", GREEN WAISTBAND COLOR, NYLON/SPANDEX, DISPOSABLE, LATEX FREE, 1EA/PK, 50PK/CS
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840216120051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216120051008402161200518402161200510840216120051

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719879646603ComfyhealthComfy Health Group Co., Ltd.ISR2025-12-08
00810113683416Three in One Belly BandManamed, Inc.ISR2025-11-25
04719879641868ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879641875ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
10810113579143ViveVIVE HEALTH LLCISR2025-05-20
10810113579150ViveVIVE HEALTH LLCISR2025-05-20
05061035460530Love NoobsROBUST VENTURES LTDISR2025-02-21
10810041981155CoreTechVIVE HEALTH LLCISR2024-09-06
06973712280043AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
06973712280050AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
20326053118511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.ISR2023-08-10
00840252901881Therafit BeltsTherafin CorporationISR2023-07-06
00840252901898Therafit BeltsTherafin CorporationISR2023-07-06
00840252901904Therafit BeltsTherafin CorporationISR2023-07-06
00840252902062Therafit BeltsTherafin CorporationISR2023-07-06
00840252902079Therafit BeltsTherafin CorporationISR2023-07-06
00840252902086Therafit BeltsTherafin CorporationISR2023-07-06
00840252902093Therafit BeltsTherafin CorporationISR2023-07-06
00840252902116Therafit BeltsTherafin CorporationISR2023-07-06
10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15
10810041980455CoreTechVIVE HEALTH LLCISR2023-02-08
00645517585567TrulifeTRULIFE LIMITEDISR2022-12-31
06974567742786EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02
06974567742793EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02
06974567742809EMSRUNWuxi Emsrun Technology Co., Ltd.ISR2022-12-02