FDA.report

Disposable Blue Non-Woven Blanket

Primary DI
00616784354132
Brand
Disposable Blue Non-Woven Blanket
Company
DYNAREX CORPORATION
Model
3541
Device description
Disposable Blue Non-Woven Blanket 44"x84"
Published
2021-09-01
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
false

Related Records

Product Codes

CodeName
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784354132PackageGS130In Commercial Distribution
00616784354118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784354132006167843541326167843541320616784354132
00616784354118006167843541186167843541180616784354118

GMDN Terms

TermDefinition
Bed blanket, single-useA large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Sterilization Methods

Method

Regulatory Flags

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

Other Devices From This Company

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 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