FDA.reportPublic FDA data

PharmChem, Inc. Transparent Overlay Film with Cutout

Primary DI
00860002279626
Brand
PharmChem, Inc. Transparent Overlay Film with Cutout
Company
PHARMCHEM, INC.
Model
Single Overlay - Rev. 3
Device description
PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
Published
2021-08-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UseGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002279626PackageGS125In Commercial Distribution
10860002279623PackageGS114In Commercial Distribution
00860001701098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002279626008600022796268600022796260860002279626
1086000227962310860002279623
00860001701098008600017010988600017010980860001701098

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-458-4100info@pharmchem.com

Regulatory Flags#

DUNS number
198063752
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001701098PharmChem, Inc. Transparent Overlay Film with CutoutSingle Overlay - Rev. 32021-08-26
00860001701005PharmChek (R) Drugs of Abuse Sweat PatchSingle Patch2019-06-30
00860001701012PharmChem, Inc. Transparent Overlay Film with CutoutSingle Overlay2019-08-31
10860001701064PharmChem, Inc. Transparent Overlay Film with CutoutSingle Overlay2019-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971257033698Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033704Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033773Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033780Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033797Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033803Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033810Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033827Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033834Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033841Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
00840118608978ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00840118602273ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00853909006518DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00853909006525DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00350770003757ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003764ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003771ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003788ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003795ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003754ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003761ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003778ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003785ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003792ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00842071131036CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00842071131043CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00860001701098PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00842071130930CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130947CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130954CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04