FDA.reportPublic FDA data

RTMED

Primary DI
06971642800829
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
80×100cm,100×200cm
Published
2022-12-07
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

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
06971642800829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642800829069716428008296971642800829

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
550402542
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
true
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
06971642801390RTMED2/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642801413RTMED2/0 75cm Cutting 3/8 30mm2024-02-22
06971642804285RTMED2 Without Needle 150cm2024-02-22
06971642804292RTMED6/0 Without Needle 150cm2024-02-22
06971642804308RTMED5/0 75cm Cutting 3/8 16mm2024-02-22
06971642804315RTMED5/0 75cm Round Bodied 1/2 13mm2024-02-22
06971642804322RTMED5/0 Without Needle 150cm2024-02-22
06971642804346RTMED4/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804353RTMED4/0 75cm Round Bodied 1/2 16mm2024-02-22
06971642804360RTMED4/0 Without Needle 150cm2024-02-22
06971642804377RTMED3/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804384RTMED3/0 75cm Cutting 3/8 24mm2024-02-22
06971642804391RTMED3/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642804407RTMED3/0 75cm Cutting 3/8 30mm2024-02-22
06971642804414RTMED3/0 75cm Round Bodied 1/2 30mm2024-02-22
06971642804421RTMED3/0 Without Needle 150cm2024-02-22
06971642801420RTMED2/0 75cm Round Bodied 1/2 24mm2024-02-23
06971642801437RTMED2/0 75cm Round Bodied 1/2 35mm2024-02-23
06971642801444RTMED2/0 Without Needle 150cm2024-02-23
06971642801451RTMED0 75cm Reverse Cutting 3/8 37mm2024-02-23

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