FDA.reportPublic FDA data

Belly Bandit

Primary DI
00191653900219
Brand
Belly Bandit
Company
The Ergo Baby Carrier Inc.
Model
90021
Catalog number
CSECUNBLK:XXL
Device description
C-Section Recovery Undies - Black - XXL
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191653900219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191653900219001916539002191916539002190191653900219

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134831606
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191653900011Belly Bandit90001DISPRUNDW2024-10-23
00191653900035Belly Bandit90003CSECDISPRUNDW2024-10-23
00191653900028Belly Bandit90002VCOOLHCPER2024-10-07
00191653900059Belly Bandit90005BFHCCPNK:O/S2025-01-10
00191653900080Belly Bandit90008GELPKUPSIE2024-10-23
00191653900066Belly Bandit90006SILBRSTBUFF:O/S2025-01-10
00191653900097Belly Bandit90009CMPSCKCHC:12025-01-10
00191653900103Belly Bandit90010CMPSCKCHC:22025-01-10
00191653900110Belly Bandit90011CMPSCKHGY:12025-01-10
00191653900127Belly Bandit90012CMPSCKHGY:22025-01-10
00191653900134Belly Bandit90013CMPSCKBLK:12025-01-10
00191653900141Belly Bandit90014CMPSCKBLK:22025-01-10
00191653900165Belly Bandit90016CSECUNBLK:XS2025-01-10
00191653900172Belly Bandit90017CSECUNBLK:S2025-01-10
00191653900189Belly Bandit90018CSECUNBLK:M2025-01-10
00191653900196Belly Bandit90019CSECUNBLK:L2025-01-10
00191653900202Belly Bandit90020CSECUNBLK:XL2025-01-10
00191653900226Belly Bandit90022CSECUNNUDE:XS2025-01-10
00191653900233Belly Bandit90023CSECUNNUDE:S2025-01-10
00191653900240Belly Bandit90024CSECUNNUDE:M2025-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
00850087488808CeeportCEEPORT INC.FQM2026-08-26
00850087488815CeeportCEEPORT INC.FQM2026-08-26
00850087488822CeeportCEEPORT INC.FQM2026-08-26
00850087488839CeeportCEEPORT INC.FQM2026-08-26
00050428124505CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFQM2026-08-14
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144666CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144673CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144680CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850087488273CeeportCEEPORT INC.FQM2026-06-08
06978479041074LotfancyAnhui Medsport Medical Products Co., Ltd.FQM2026-06-03
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26