FDA.report

meijer

Primary DI
10713733229200
Brand
meijer
Company
MEIJER, INC.
Model
713733229203
Catalog number
4300495
Device description
Extreme Hydrocolloid blister cushion, all one size, 42 mm x 68 mm
Published
2019-06-28
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
true

Related Records

Product Codes

CodeName
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10713733229200PackageGS124In Commercial Distribution
00713733229203PrimaryGS10
60713733229205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1071373322920010713733229200
00713733229203007137332292037137332292030713733229203
6071373322920560713733229205

GMDN Terms

TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-sterileA non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
006959555
Device count
5
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00713733567404MeijerVBM736EC12024-04-17
00719283338334Meijer Hot & Cold Compression Migraine Mask7192833383342024-04-03

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