FDA.reportPublic FDA data

Belly Bandit

Primary DI
00191653900127
Brand
Belly Bandit
Company
The Ergo Baby Carrier Inc.
Model
90012
Catalog number
CMPSCKHGY:2
Device description
Postpartum & Maternity Compression Socks - Heathered Grey (Size 2)
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
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191653900127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191653900127001916539001271916539001270191653900127

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. 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
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
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
00191653900219Belly Bandit90021CSECUNBLK:XXL2025-01-10
00191653900226Belly Bandit90022CSECUNNUDE:XS2025-01-10
00191653900233Belly Bandit90023CSECUNNUDE:S2025-01-10
00191653900240Belly Bandit90024CSECUNNUDE:M2025-01-10
00191653900257Belly Bandit90025CSECUNNUDE:L2025-01-10
00191653900264Belly Bandit90026CSECUNNUDE:XL2025-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204011Compression StockingGottfried Medical, Inc.FQL2026-06-04