Custom Healthcare Systems, Inc.

GUDID 20811870035153

CUSTOM HEALTHCARE SYSTEMS, INC.

General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use
Primary Device ID20811870035153
NIH Device Record Key82ffd3dc-89d6-47b1-b903-e053268b5adf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Healthcare Systems, Inc.
Version Model NumberB9-19853
Company DUNS175254820
Company NameCUSTOM HEALTHCARE SYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS100811870035159 [Primary]
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution
GS120811870035153 [Package]
Contains: 00811870035159
Package: NA [100 Units]
In Commercial Distribution

FDA Product Code

KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile
KXGApplicator, Absorbent Tipped, Sterile

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


[20811870035153]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Custom Healthcare Systems, Inc.]

20811870032930L4000
20811870032923M400
20811870033326YMCIR-800
20811870033401BTPS 203
20811870033371BTPS 202
20811870032671BTPS 004M
20811870032268BTPS 004S
20811870033418JPK-19181 2
20811870033470KM-19370
20811870035733L1000-19338
20811870033678SJ-19441
20811870033715B9-15323E
20811870033784M100-19565
00811870033773JBV005
20811870033937B9-19530
20811870033883B9-19531
20811870033845B9-19529
20811870034231L4000-19622
20811870034286R1553
20811870034293CUS1174
20811870034460CUS1173
208118700345903404922
20811870035924CUS1797
20811870035030DT-19714
20811870033647B9-19462
20811870033623B8-17070
20811870033562BTPS 005XL
20811870033524CHC-19139
20811870033517B9-15323D
20811870035337LEM011-01
20811870034743M200-19756
20811870034736M200-19733
20811870034750UVA-19787
20811870034767CUS1871
20811870034774BMTX-1009D
20811870034781ZZ-0666
20811870034811Nine011
20811870034798NINE010
20811870034682B9-19797
20811870034903IHI-19697
20811870034910BMTX-1047
20811870035054B9-19810
20811870035085B9-19811
20811870035078M200-19808
20811870035061KM3404942
20811870035092UVA-19787
20811870035108B9-19785
20811870034842B9-19784
20811870035153B9-19853
20811870034927KM3405353-1

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