FDA.reportPublic FDA data

AffloShield

Primary DI
10814321020466
Brand
AffloShield
Company
Movair, Inc.
Model
8600
Catalog number
8600
Device description
The AffloShield is a disposable gown intended for use with the AffloVest product line.
Published
2019-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814321020466PrimaryGS10
00814321020469Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081432102046610814321020466
00814321020469008143210204698143210204690814321020469

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788403103
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013561406MPVMV50012025-03-12
00860013561413MPVMV50002025-03-12
10814321020152"FloProbe 1/4’’ x 1/4"" (Non Sterile)"3090N2016-07-12
10814321020176FloProbe 3/8’’ x 3/8” (Non Sterile)3080N 2016-07-12
10814321020213IBC Aortic Punch, Long, 2.8mmAPL282016-08-02
10814321020220IBC Aortic Punch, Long, 3.6mmAPL36 2016-08-02
10814321020237IBC Aortic Punch, Long, 4.0mmAPL402016-08-02
10814321020244IBC Aortic Punch, Long, 4.4mmAPL442016-08-02
10814321020251IBC Aortic Punch, Long, 4.8mmAPL482016-08-02
10814321020268IBC Aortic Punch, Long, 5.2mmAPL522016-08-02
10814321020275IBC Aortic Punch, Long, 5.6mmAPL562016-08-02
10814321020282IBC Aortic Punch, Long, 6.0mmAPL602016-08-02
10814321020299IBC Aortic Punch, Medium, 2.8mmAPM282016-08-02
10814321020305IBC Aortic Punch, Medium, 3.6mmAPM362016-08-02
10814321020312IBC Aortic Punch, Medium, 4.0mmAPM402016-08-02
10814321020329IBC Aortic Punch, Medium, 4.4mmAPM442016-08-02
10814321020336IBC Aortic Punch, Medium, 4.8mmAPM482016-08-02
10814321020343IBC Aortic Punch, Medium, 5.2mmAPM522016-08-02
10814321020350IBC Aortic Punch, Medium, 5.6mmAPM562016-08-02
10814321020367IBC Aortic Punch, Medium, 6.0mmAPM602016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158970MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158987MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159014MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159106MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196247616MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196730248MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24