FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216102668
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
HWT202
Device description
BOUFFANT CAP BLUE 24IN, 1/BX,500/CS (100/BX,5BX/CS,500/CS)
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216102668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216102668008402161026688402161026680840216102668

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344202212MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
10810132043779HCSConcordance Healthcare Solutions LLCFYF2026-01-15
06979032640086GOBENHUZHOU JUNDA INDUSTRY CO., LTD.FYF2025-08-26
10813360021519ProtexerICP MEDICAL, LLCFYF2025-08-19
00810184641346GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641353GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641360GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641377GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641384GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184642442GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859211GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859877GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859129GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
00850061859143GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
10827989003641Health Care Logistics, Inc®Health Care Logistics, Inc.FYF2025-04-22
TQ26126151700Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151990Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152000Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
20810141933235VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933242VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933259VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933266VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933273VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933280VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933297VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933303VIVIT SupplyVivit Supply LLCFYF2024-11-29
14719882252522CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252546CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252560CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252584CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06