FDA.reportPublic FDA data

Plastic Headrest Covers

Primary DI
00616784215334
Brand
Plastic Headrest Covers
Company
DYNAREX CORPORATION
Model
2153
Device description
Plastic Headrest Covers- Medium 9.5"x11"
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784215334PackageGS112In Commercial Distribution
00616784215327PrimaryGS10
00616784215310Unit of UseGS10
00810180843270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784215334006167842153346167842153340616784215334
00616784215327006167842153276167842153270616784215327
00616784215310006167842153106167842153100616784215310
00810180843270008101808432708101808432700810180843270

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
250
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859149975678DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00885914997581DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
08859149976040DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00850001780353CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00850001780377CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00748426261284Medline-MicrotekMicrotek Medical LLCKME2026-01-28
00810180842440Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, UniversalDynarex CorporationKME2026-01-05
00850056748230FORWARD APLS Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-11-25
M68904106020HI-VIS Emergency BlanketSafeguard US Operating, LLCKME2025-09-15
00304040193150Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
00850056748483FORWARD HEAT - Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-09-02
06979032640093GOBENHUZHOU JUNDA INDUSTRY CO., LTD.KME2025-08-26
50192253014424CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
00850061859785GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859792GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859808GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859815GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859822GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859839GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859846GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859853GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
16975675788564RESCUE ESSENTIALSEMSRUN GROUPKME2025-07-18
06931918194168AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
06931918129818HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
00616784134420DynaCare Disposable Underpads, Compressed Packaging, Absorbent Fluff Fill Dynarex CorporationKME2025-06-10
08938504806793Pinnakle Moderate UnderpadPHU BAO GROUP COMPANY LIMITEDKME2025-05-30
20889483602918AirLife™AirLife Finland OyKME2025-04-17
20889483602925AirLife™AirLife Finland OyKME2025-04-17
20889483602932AirLife™AirLife Finland OyKME2025-04-17
20889483602949AirLife™AirLife Finland OyKME2025-04-17