FDA.report

Belly Bandit

Primary DI
00191653900141
Brand
Belly Bandit
Company
The Ergo Baby Carrier Inc.
Model
90014
Catalog number
CMPSCKBLK:2
Device description
Postpartum & Maternity Compression Socks - Black (Size 2)
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191653900141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191653900141001916539001411916539001410191653900141

GMDN Terms

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

Regulatory Flags

DUNS number
134831606
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00191653900059Belly Bandit90005BFHCCPNK:O/S2025-01-10
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
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
00191653900271Belly Bandit90027CSECUNNUDE:XXL2025-01-10
00191653900011Belly Bandit90001DISPRUNDW2024-10-23

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