FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870030905
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
R1668
Published
2018-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870030905PackageGS136In Commercial Distribution
00811870030901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003090520811870030905
00811870030901008118700309018118700309010811870030901

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool roll, sterileA device designed as an absorbent, sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector; it is not in the form of a bandage or dedicated dressing. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20811870035757Custom Healthcare Systems of VA, LLCCPT56102021-08-11
20811870035962Custom Healthcare Systems of VA, LLCCPT55002021-08-11
20811870035702Custom Healthcare Systems of VA, LLCA2081V-62021-08-09
20811870035740Custom Healthcare Systems of VA, LLCB9-16350D2021-08-09
20811870035689Custom Healthcare Systems of VA, LLCOSC-200612021-07-30
20811870035665Custom Healthcare Systems of VA, LLCDT-193432021-07-15
20811870035672Custom Healthcare Systems of VA, LLCB9-9754A2021-07-15
20811870035634Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
20811870035580Custom Healthcare Systems of VA, LLCL4000-200272021-07-06
20811870035566Custom Healthcare Systems of VA, LLCKM-19796-12021-06-29
20811870035535Custom Healthcare Systems of VA, LLCB9-200082021-06-18
20811870035559Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
20811870035498Custom Healthcare Systems of VA, LLC36774662021-06-11
20811870035474Custom Healthcare Systems of VA, LLCL1000-199362021-06-10
20811870035528Custom Healthcare Systems of VA, LLCL1000-200002021-06-10
20811870035450Custom Healthcare Systems of VA, LLCMWM-18937-022021-06-04
20811870035443Custom Healthcare Systems of VA, LLCZZ-14112021-05-24
20811870035306Custom Healthcare Systems of VA, LLCZZ-14102021-05-07
20811870035382Custom Healthcare Systems of VA, LLCZZ-14132021-05-07
20811870035399Custom Healthcare Systems of VA, LLCZZ-14122021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
00850087488808CeeportCEEPORT INC.FQM2026-08-26
00850087488815CeeportCEEPORT INC.FQM2026-08-26
00850087488822CeeportCEEPORT INC.FQM2026-08-26
00850087488839CeeportCEEPORT INC.FQM2026-08-26
00050428124505CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFQM2026-08-14
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144666CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144673CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144680CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850087488273CeeportCEEPORT INC.FQM2026-06-08
06978479041074LotfancyAnhui Medsport Medical Products Co., Ltd.FQM2026-06-03
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26